List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices

for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

BSK - CUFF, TRACHEAL TUBE, INFLATABLE

BSZ - GAS-MACHINE, ANESTHESIA

2
2

Y
Y

N
N

BTL - VENTILATOR, EMERGENCY, POWERED

(RESUSCITATOR)

BTM - VENTILATOR, EMERGENCY, MANUAL

(RESUSCITATOR)

BTO - TUBE, TRACHEOSTOMY (W/WO

CONNECTOR)

BTR - TUBE, TRACHEAL (W/WO CONNECTOR)

BTS - TUBE, BRONCHIAL (W/WO CONNECTOR)

BWC - NEEDLE, EMERGENCY AIRWAY

BYE - ATTACHMENT, BREATHING, POSITIVE END

EXPIRATORY PRESSURE

BYK - TENT, OXYGEN, ELECTRICALLY POWERED

BYT - VENTILATOR, EXTERNAL BODY, NEGATIVE

PRESSURE, ADULT (CUIRASS)

BZR - MIXER, BREATHING GASES, ANESTHESIA

INHALATION

CAC - APPARATUS, AUTOTRANSFUSION

CAG - CIRCULATOR, BREATHING-CIRCUIT

CAO - AIRWAY, ESOPHAGEAL (OBTURATOR)

CAW - GENERATOR, OXYGEN, PORTABLE

CBF - CHAMBER, HYPERBARIC

2
2

Y
Y

N
N

CBI - TUBE, TRACHEAL/BRONCHIAL,

DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

CBK - VENTILATOR, CONTINUOUS, FACILITY USE

CBO - ATTACHMENT, INTERMITANT MANDATORY

VENTILATION (IMV)
CBP - VALVE, NON-REBREATHING

2
2

Y
Y

N
N

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

CCO - BED, ROCKING, BREATHING ASSIST

DRO - PACEMAKER, CARDIAC, EXTERNAL

TRANSCUTANEOUS (NON-INVASIVE)
DSS - CLIP, VASCULAR
DST - CLIP, VENA-CAVA

2
2
2

Y
N
N

N
Y
Y

DSW - BAG, POLYMERIC MESH, PACEMAKER

DSY - PROSTHESIS, VASCULAR GRAFT, OF 6MM

AND GREATER DIAMETER

DTD - PACEMAKER LEAD ADAPTOR

DTK - FILTER, INTRAVASCULAR,

CARDIOVASCULAR

DTM - FILTER, BLOOD, CARDIOPULMONARY

BYPASS, ARTERIAL LINE

DTP - DEFOAMER, CARDIOPULMONARY BYPASS

DTQ - CONSOLE, HEART-LUNG MACHINE,

CARDIOPULMONARY BYPASS

DTR - HEAT-EXCHANGER, CARDIOPULMONARY

BYPASS

DTX - GAS CONTROL UNIT, CARDIOPULMONARY

BYPASS

DTZ - OXYGENATOR, CARDIOPULMONARY

BYPASS

DWA - CONTROL, PUMP SPEED,

CARDIOPULMONARY BYPASS

DWB - PUMP, BLOOD, CARDIOPULMONARY

BYPASS, ROLLER TYPE

DWC - CONTROLLER, TEMPERATURE,

CARDIOPULMONARY BYPASS

DXZ - PATCH, PLEDGET AND INTRACARDIAC,

PETP, PTFE, POLYPROPYLENE

DYF - PROSTHESIS, VASCULAR GRAFT, OF LESS

THEN 6MM DIAMETER

DYX - LOCK, WIRE, AND LIGATURE, INTRAORAL

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

DZE - IMPLANT, ENDOSSEOUS, ROOT-FORM

DZK - WIRE, FIXATION, INTRAOSSEOUS

DZL - SCREW, FIXATION, INTRAOSSEOUS

ELE - IMPLANT, SUBPERIOSTEAL

2
2

N
N

Y
Y

ESF - POLYMER, COMPOSITE SYNTHETIC PTFE

WITH CARBON-FIBER, ENT

ESH - POLYMER, ENT SYNTHETIC-PIFE, SILICON

ELASTOMER, POLYETHYLENE, POLYURETHANE
ESW - PROSTHESIS, ESOPHAGEAL

2
2

N
N

Y
Y

ESX - TACK, SACCULOTOMY (CODY TACK)

ESY - PROSTHESIS, OTOPLASTY

2
2

N
N

Y
Y

ESZ - TUBE, SHUNT, ENDOLYMPHATIC

ETA - REPLACEMENT, OSSICULAR PROSTHESIS,

TOTAL

ETB - PROSTHESIS, PARTIAL OSSICULAR

REPLACEMENT
ETC - MOLD, MIDDLE-EAR
ETD - TUBE, TYMPANOSTOMY
EZX - MESH, SURGICAL, METAL
FAD - STENT, URETERAL
FAE - PROSTHESIS, PENILE

2
2
2
2
2
2

N
N
N
N
N
N

Y
Y
Y
Y
Y
Y

FEZ - CATHETER AND TUBE, SUPRAPUBIC

FGE - CATHETER, BILIARY, DIAGNOSTIC

FHS - DIALYZER, SINGLE COIL

2
2

Y
Y

Y
N

FIB - PROTECTOR, TRANSDUCER, DIALYSIS

FID - TUBING, DIALYSATE

2
2

Y
Y

N
N

FIF - SET, DIALYSIS, SINGLE NEEDLE WITH UNIDIRECTIONAL PUMP

FIG - CLAMP, TUBING, BLOOD, AUTOMATIC

FIH - PUMP, INFUSION OR SYRINGE, EXTRALUMINAL

FII - SYSTEM, DIALYSATE DELIVERY, SEALED

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

FIJ - SYSTEM, DIALYSATE DELIVERY,

RECIRCULATING, SINGLE PASS

FIK - SYSTEM, DIALYSATE DELIVERY,

RECIRCULATING

FIL - SYSTEM, DIALYSATE DELIVERY, SINGLE

PASS

FIR - PUMP, BLOOD, EXTRA-LUMINAL

FIS - FLOWMETER, DIALYSATE
FIW - ALARM, PILLOW PRESSURE

2
2
2

Y
Y
Y

N
N
N

FIZ - METER, CONDUCTIVITY, NON-REMOTE

FJB - DETECTOR, DIALYSATE LEVEL

FJC - DETECTOR, BLOOD LEVEL
FJD - DETECTOR, LEAK, BLOOD
FJF - DETECTOR, AIR BUBBLE
FJG - DIALYZER, PARALLEL FLOW
FJH - DIALYZER, DISPOSABLE

2
2
2
2
2
2

Y
Y
Y
Y
Y
Y

N
N
N
N
N
N

FJI - DIALYZER, CAPILLARY, HOLLOW FIBER

FJJ - DIALYZER, TWIN COIL

2
2

Y
Y

N
N

FJK - SET, TUBING, BLOOD, WITH AND WITHOUT

ANTI-REGURGITATION VALVE

FJS - CATHETER, PERITONEAL, LONG-TERM

INDWELLING
FJT - INTRACATHETER, DIALYSIS

2
2

N
Y

Y
N

FKB - CONNECTOR, BLOOD TUBING, INFUSION T

FKC - CLAMP, CANNULA
FKD - CANISTER, COIL
FKJ - FILTER, BLOOD, DIALYSIS
FKL - INSERT, PUMP, BLOOD
FKN - ADAPTOR, SHUNT

2
1
2
2
2
2

Y
N
Y
Y
Y
N

N
Y
N
N
N
Y

FKO - CATHETER, PERITONEAL DIALYSIS, SINGLE

USE

FKP - SYSTEM, DIALYSATE DELIVERY, SINGLE

PATIENT

FKQ - SYSTEM, DIALYSATE DELIVERY, CENTRAL

MULTIPLE PATIENT

FKR - SUBSYSTEM, PROPORTIONING

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

FKT - SYSTEM, DIALYSATE DELIVERY, SORBENT

REGENERATED

FKX - SYSTEM, PERITONEAL, AUTOMATIC

DELIVERY

FKY - CONNECTOR, TUBING, DIALYSATE

FLA - MONITOR, TEMPERATURE, DIALYSIS

FLC - STATION, DIALYSIS CONTROL, NEGATIVE

PRESSURE TYPE

FLS - MONITOR, APNEA, FACILITY USE

FTL - MESH, SURGICAL, POLYMERIC

FTM - MESH, SURGICAL

2
2

N
N

Y
Y

FTQ - PROSTHESIS, PENIS, RIGID ROD

FWP - PROSTHESIS, CHIN, INTERNAL

FZD - PROSTHESIS, EAR, INTERNAL

FZE - PROSTHESIS, NOSE, INTERNAL

FZP - CLIP, IMPLANTABLE
GAK - SUTURE, ABSORBABLE

2
2
2

N
N
N

Y
Y
Y

GAL - SUTURE, ABSORBABLE, NATURAL

GAM - SUTURE, ABSORBABLE, SYNTHETIC,

POLYGLYCOLIC ACID

GAN - SUTURE, ABSORBABLE, SYNTHETIC

GAO - SUTURE, NONABSORBABLE

2
Unclassified

N
N

Y
Y

GAP - SUTURE, NONABSORBABLE, SILK

GAQ - SUTURE, NONABSORBABLE, STEEL,

MONOFILAMENT AND MULTIFILAMENT, STERILE

GAR - SUTURE, NONABSORBABLE, SYNTHETIC,

POLYAMIDE

GAS - SUTURE, NONABSORBABLE, SYNTHETIC,

POLYESTER

GAT - SUTURE, NONABSORBABLE, SYNTHETIC,

POLYETHYLENE

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

GAW - SUTURE, NONABSORBABLE, SYNTHETIC,

POLYPROPYLENE
GDW - STAPLE, IMPLANTABLE

2
2

N
N

Y
Y

GWO - PLATE, CRANIOPLASTY, PREFORMED,

ALTERABLE

GXN - PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

GXO - STRIP, CRANIOSYNOSTOSIS, PREFORMED

GXP - METHYL METHACRYLATE FOR

CRANIOPLASTY
GXQ - DURA SUBSTITUTE
GXR - COVER, BURR HOLE

2
2
2

N
N
N

Y
Y
Y

GZB - STIMULATOR, SPINAL-CORD, IMPLANTED

(PAIN RELIEF)

GZF - STIMULATOR, PERIPHERAL NERVE,

IMPLANTED (PAIN RELIEF)

HBP - CLIP, IMPLANTED MALLEABLE

HBW - FASTENER, PLATE, CRANIOPLASTY

HCE - CLAMP, CAROTID ARTERY

2
2

N
N

Y
Y

HCG - DEVICE, NEUROVASCULAR EMBOLIZATION

HCH - CLIP, ANEURYSM

2
2

N
N

Y
Y

HFJ - PROSTHESIS, FALLOPIAN TUBE

HPZ - IMPLANT, EYE SPHERE

2
2

N
N

Y
Y

HQJ - IMPLANT, ABSORBABLE, (SCLERAL

BUCKLING METHODS)

HQM - KERATOPROSTHESIS, PERMANENT

IMPLANT
HQT - SHELL, SCLERAL

2
2

N
N

Y
Y

HQW - CLIP, TANTALUM, OPHTHALMIC

HQX - IMPLANT, ORBITAL, EXTRA-OCULAR

HRS - PLATE, FIXATION, BONE

2
2

N
N

Y
Y

HRY - PROSTHESIS, KNEE, FEMOROTIBIAL, SEMICONSTRAINED, CEMENTED, METAL/POLYMER

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

HSB - ROD, FIXATION, INTRAMEDULLARY AND

ACCESSORIES

HSD - PROSTHESIS, SHOULDER, HEMI-, HUMERAL,

METALLIC UNCEMENTED

HSH - PROSTHESIS, KNEE, HEMI-, TIBIAL,

RESURFACING (UNCEMENTED)

HSN - PROSTHESIS, ANKLE, SEMI-CONSTRAINED,

CEMENTED, METAL/POLYMER

HSX - PROSTHESIS, KNEE, FEMOROTIBIAL, NONCONSTRAINED, CEMENTED, METAL/POLYMER

HTG - PROSTHESIS, KNEE, HEMI-, PATELLAR

RESURFACING, UNCEMENTED
HTN - WASHER, BOLT NUT
HTY - PIN, FIXATION, SMOOTH
HWC - SCREW, FIXATION, BONE

2
2
2
2

N
N
N
N

Y
Y
Y
Y

HXA - PROSTHESIS, TENDON, PASSIVE

IWG - SEED, ISOTOPE, GOLD, TITANIUM,

PLATINUM

JAZ - PROSTHESIS, FACIAL, MANDIBULAR

IMPLANT
JCQ - PROSTHESIS, ESOPHAGUS
JCS - PROSTHESIS, MAXILLA

2
2
Unclassified

N
N
N

Y
Y
Y

JCT - PROSTHESIS, TRACHEAL, EXPANDABLE

JDB - PROSTHESIS, ELBOW, SEMI-CONSTRAINED,

CEMENTED

JDC - PROSTHESIS, ELBOW, CONSTRAINED,

CEMENTED

JDD - PROSTHESIS, UPPER FEMORAL

JDG - PROSTHESIS, HIP, FEMORAL COMPONENT,

CEMENTED, METAL

JDH - PROSTHESIS, HIP, HEMI-, TRUNNIONBEARING, FEMORAL, METAL/POLYACETAL

Not
Classified

JDI - PROSTHESIS, HIP, SEMI-CONSTRAINED,

METAL/POLYMER, CEMENTED

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

JDJ - MESH, SURGICAL, ACETABULAR, HIP,

PROSTHESIS

JDK - PROSTHESIS, HIP, CEMENT RESTRICTOR

JDN - IMPLANT, FIXATION DEVICE, SPINAL

JDO - DEVICE, FIXATION, PROXIMAL FEMORAL,

IMPLANT

JDP - CONDYLAR PLATE FIXATION IMPLANT

JDQ - CERCLAGE, FIXATION
JDR - STAPLE, FIXATION, BONE
JDS - NAIL, FIXATION, BONE
JDT - CAP, BONE
JDW - PIN, FIXATION, THREADED

2
2
2
2
1
2

N
N
N
N
N
N

Y
Y
Y
Y
Y
Y

JEC - COMPONENT, TRACTION, INVASIVE

JEY - PLATE, BONE

2
2

N
N

Y
Y

JOF - POLYMER, ENT SYNTHETIC, POROUS

POLYETHYLENE

JOH - TUBE TRACHEOSTOMY AND TUBE CUFF

JOQ - GENERATOR, PULSE, PACEMAKER,

EXTERNAL PROGRAMMABLE

JWH - PROSTHESIS, KNEE,

PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
CEMENTED, POLYMER/METAL/POLYMER

JWI - PROSTHESIS, WRIST, 2 PART METALPLASTIC ARTICULATION, SEMI-CONSTRAINED

JWJ - PROSTHESIS, WRIST, 3 PART METALPLASTIC-METAL ARTICULATION, SEMICONSTRAINED

JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND

COMPONENTS

JXH - METHYL METHACRYLATE FOR

ANEURYSMORRHAPHY
JXI - CUFF, NERVE

2
2

N
N

Y
Y

KDA - PROSTHESIS, PTFE/CARBON-FIBER

KDI - DIALYZER, HIGH PERMEABILITY WITH OR

WITHOUT SEALED DIALYSATE SYSTEM

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

KDJ - SET, ADMINISTRATION, FOR PERITONEAL

DIALYSIS, DISPOSABLE

KHJ - POLYMER, ENT SYNTHETIC-POLYAMIDE

(MESH OR FOIL MATERIAL)

KHK - POLYMER, ENT NATURAL-COLLAGEN

MATERIAL

Unclassified

KIG - PROSTHESIS, WRIST, CONSTRAINED,

POLYMER

KKY - MATERIAL, POLYTETRAFLUOROETHYLENE

VITREOUS CARBON, FOR MAXILLOFACIAL
RECONSTRUCTION

KLZ - TUBE, SHUNT, ENDOLYMPHATIC WITH

VALVE

KMB - PROSTHESIS, KNEE, NON-CONSTRAINED

(METAL-CARBON REINFORCED POLYETHYLENE)
CEMENTED

KMC - PROSTHESIS, HIP, SEMI-CONSTRAINED,

COMPOSITE/METAL

KMD - PROSTHESIS, ANKLE, SEMI-CONSTRAINED,

CEMENTED, METAL/COMPOSITE

KNR - ADAPTER, A-V SHUNT OR FISTULA

KNZ - ACCESSORIES, A-V SHUNT

2
2

N
N

Y
Y

KOB - CATHETER, SUPRAPUBIC (AND

ACCESSORIES)

KOC - ACCESSORIES, BLOOD CIRCUIT,

HEMODIALYSIS

KPF - SYSTEM, DIALYSATE DELIVERY, SEMIAUTOMATIC, PERITONEAL

KPK - MARKER, OSTIA, AORTO-SAPHENOUS VEIN

KPM - SHUNT, PERITONEAL

2
2

N
N

Y
Y

KPO - DIALYSATE CONCENTRATE FOR

HEMODIALYSIS (LIQUID OR POWDER)

KPP - PERITONEAL DIALYSATE FILTER

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

KQL - TUBE, TYMPANOSTOMY WITH SEMIPERMEABLE MEMBRANE

KQQ - TUBING, DIALYSATE (AND CONNECTOR)

KQR - DETECTOR, AIR OR FOAM

2
2

Y
Y

N
N

KRD - DEVICE, VASCULAR, FOR PROMOTING

EMBOLIZATION
KRH - RING, ANNULOPLASTY

2
2

N
N

Y
Y

KRO - PROSTHESIS, KNEE, FEMOROTIBIAL,

CONSTRAINED, CEMENTED, METAL/POLYMER

KRQ - PROSTHESIS, KNEE,

PATELLO/FEMOROTIBIAL, CONSTRAINED,
CEMENTED, POLYMER/METAL/POLYMER

KRR - PROSTHESIS, KNEE, PATELLO/FEMORAL,

SEMI-CONSTRAINED, CEMENTED,
METAL/POLYMER

KTT - APPLIANCE, FIXATION, NAIL/BLADE/PLATE

COMBINATION, MULTIPLE COMPONENT

KTW - APPLIANCE, FIXATION, NAIL/BLADE/PLATE

COMBINATION, SINGLE COMPONENT

KTX - PROSTHESIS, KNEE, FEMOROTIBIAL, NONCONSTRAINED, METAL/COMPOSITE CEMENTED

KWD - PROSTHESIS, TOE, HEMI-, PHALANGEAL

KWF - PROSTHESIS, FINGER, POLYMER

KWH - PROSTHESIS, TOE, CONSTRAINED,

POLYMER

KWI - PROSTHESIS, ELBOW, HEMI-, RADIAL,

POLYMER

KWK - APPLIANCE, NAIL/BLADE/PLATE

COMBINATION, SINGLE COMPONENT

KWL - PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

KWM - PROSTHESIS, WRIST, SEMI-CONSTRAINED

10

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

KWN - PROSTHESIS, WRIST, CARPAL LUNATE

KWO - PROSTHESIS, WRIST, CARPAL SCAPHOID

KWP - APPLIANCE, FIXATION, SPINAL

INTERLAMINAL

KWQ - APPLIANCE, FIXATION, SPINAL

INTERVERTEBRAL BODY

KWS - PROSTHESIS, SHOULDER, SEMICONSTRAINED, METAL/POLYMER CEMENTED

KWT - PROSTHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED

KWY - PROSTHESIS, HIP, HEMI-, FEMORAL,

METAL/POLYMER, CEMENTED OR UNCEMENTED

KWZ - PROSTHESIS, HIP, CONSTRAINED,

CEMENTED OR UNCEMENTED, METAL/POLYMER

KXA - PROSTHESIS, HIP, FEMORAL, RESURFACING

KXE - PROSTHESIS, WRIST, HEMI-, ULNAR

KXK - SOURCE, BRACHYTHERAPY, RADIONUCLIDE

KXM - SYSTEM ACCESSORIES, EXTRACORPOREAL

KYF - IMPLANT, EYE VALVE

2
2

Y
N

N
Y

KYI - PROSTHESIS, WRIST, CARPAL TRAPEZIUM

KYJ - PROSTHESIS, FINGER, CONSTRAINED,

POLYMER

KYK - PROSTHESIS, KNEE, FEMOROTIBIAL, SEMICONSTRAINED, CEMENTED, METAL/COMPOSITE

LBL - TUBE, TYMPANOSTOMY, POROUS

POLYETHYLENE

LBM - POROUS POLYETHYLENE OSSICULAR

REPLACEMENT

LBN - REPLACEMENT, TOTAL OSSICULAR,

PROSTHESIS, POROUS, POLYETHYLENE

11

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

LBP - REPLACEMENT, OSSICULAR (STAPES)

USING ABSORBABLE GELATIN MATERIAL

LCJ - EXPANDER, SKIN, INFLATABLE

Unclassified

LDD - DC-DEFIBRILLATOR, LOW-ENERGY,

(INCLUDING PADDLES)

LDF - ELECTRODE, PACEMAKER, TEMPORARY

LEM - HUMAN LYOPHILIZED DURA MATER

LFB - BUTTON, NASAL SEPTAL
LFK - CATHETER, FEMORAL

2
Unclassified
2

N
N
Y

Y
Y
Y

LGE - PROSTHESIS, KNEE, FEMOROTIBIAL, SEMICONSTRAINED, CEMENTED, TRUNNION-BEARING

LGK - PROSTHESIS, MAXILLOFACIAL

Not
Classified

LHG - ELECTRODE, SPINAL EPIDURAL

LJS CATHETER,INTRAVASCULAR,THERAPEUTIC,LONGTERM GREATER THAN 30 DAYS

LJT - PORT & CATHETER, IMPLANTED,

SUBCUTANEOUS, INTRAVASCULAR

LKG - PORT & CATHETER, IMPLANTED,

SUBCUTANEOUS, INTRAVENTRICULAR

Unclassified

LLB - SYSTEM, BLOOD, EXTRACORPOREAL AND

ACCESSORIES

LLD - PORT & CATHETER, IMPLANTED,

SUBCUTANEOUS, INTRAPERITONEAL
LOD - BONE CEMENT

Unclassified
2

N
N

Y
Y

LPH - PROSTHESIS, HIP, SEMI-CONSTRAINED,

METAL/POLYMER, POROUS UNCEMENTED

LPK - BONE GRAFTING MATERIAL, FOR DENTAL

BONE REPAIR

LQS - SPERMATOCELE, ALLOPLASTIC

Unclassified

12

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

LRI - PH METER FOR DIALYSIS HYDROGEN ION

CONCENTRATION

LWJ - PROSTHESIS, HIP, SEMI-CONSTRAINED,

METAL/POLYMER, UNCEMENTED

LXT - APPLIANCE, FIXATION, NAIL/BLADE/PLATE

COMBINATION, MULTIPLE COMPONENT, METAL
COMPOSITE

LYC - BONE GRAFTING MATERIAL, SYNTHETIC

LYP - ACCESSORIES, FIXATION, SPINAL

INTERLAMINAL
LYT - FIXATION ACCESSORY

2
2

N
N

Y
Y

LZJ - PROSTHESIS, TOE

(METATARSOPHALANGEAL), JOINT,
METAL/POLYMER, SEMI-CONSTRAINED
LZK - IMPLANT, MALAR
LZN - CEMENT OBTURATOR

Unclassified
Unclassified
2

N
N
N

Y
Y
Y

LZO - PROSTHESIS, HIP, SEMI-CONSTRAINED,

METAL/CERAMIC/POLYMER, CEMENTED OR NONPOROUS, UNCEMENTED

LZY - PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

BALL

MAH - HEARING AID, BONE CONDUCTION,

IMPLANTED

MAL - GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC

COMPOSITE

MAX - INTERVERTEBRAL FUSION DEVICE WITH

BONE GRAFT, LUMBAR

MAY - PROSTHESIS, HIP, SEMI-CONSTRAINED,

METAL/CERAMIC/POLYMER, CEMENTED OR NONPOROUS CEMENTED, OSTEOPHILIC FINISH

MAZ - PROSTHESIS, HIP, SEMI-CONSTRAINED,

METAL/POLYMER, POROUS UNCEMENTED,
OSTEOPHILIC FINISH
MBB - BONE CEMENT, ANTIBIOTIC

Not
Classified
2

N
N

Y
Y

MBF - PROSTHESIS, SHOULDER, SEMICONSTRAINED, METAL/POLYMER, UNCEMENTED

13

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

MBH - PROSTHESIS, KNEE,

PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED,
UNCEMENTED, POROUS, COATED,
POLYMER/METAL/POLYMER

MBI - FASTENER, FIXATION, NONDEGRADABLE,

SOFT TISSUE

MBL - PROSTHESIS, HIP, SEMI-CONSTRAINED,

UNCEMENTED, METAL/POLYMER, POROUS

MBM - PROSTHESIS, HIP, SEMI-CONSTRAINED OR

HEMI-, METAL/PTFE COATED/POLYMER,
CEMENTED OR UN-CEMENTED

Not
Classified

MBP - FILLER, BONE VOID, OSTEOINDUCTION (W/O

HUMAN GROWTH FACTOR)

MBV - PROSTHESIS, KNEE,

PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED,
UHMWPE, PEGGED, UNCEMENTED,
POLYMER/METAL/POLYMER

MBZ - INSTRUMENT, ELECTROSURGICAL, FIELD

FOCUSED
MCA - TAPE, SURGICAL, INTERNAL
MCH - CLIP, HEMOSTATIC

Not
Classified
Unclassified
2

N
N
N

Y
Y
Y

MDL - IMPLANT, TRANSMANDIBULAR

MDO - FIBRILLATOR, AC, INTERNAL

2
Not
Classified

MDV - PORT & CATHETER, INFUSION, IMPLANTED,

SUBCUTANEOUS, INTRASPINAL

Not
Classified

MDX - PORT & CATHETER, INFUSION, IMPLANTED,

SUBCUTANEOUS, INTRAPERITONEAL

Not
Classified

MEH - PROSTHESIS, HIP, SEMI-CONSTRAINED,

UNCEMENTED, METAL/POLYMER, NON-POROUS,
CALICUM-PHOSPHATE

MEJ - PROSTHESIS, HIP, SEMI-CONSTRAINED,

COMPOSITE/POLYMER

Not
Classified

MFC - CATHETER, OCCLUDING,

CARDIOVASCULAR, IMPLANTABLE

Not
Classified

14

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

MFH - IMPLANT, INTEGRATED TISSUE

Not
Classified

MHC - PORT, INTRAOSSEOUS, IMPLANTED

MIB - ELASTOMER, SILICONE BLOCK

MIC - IMPLANT, MUSCLE, PECTORALIS

Unclassified

MIX - SYSTEM, VOCAL CORD MEDIALIZATION

MJW - PROSTHESIS, SUBTALAR, PLUG, POLYMER

Unclassified

MLB - DEVICE, REPEAT ACCESS (ABDOMEN)

Not
Classified

MLP - KERATOPROSTHESIS, TEMPORARY

IMPLANT, SURGICAL USE

MLW - WARMER, PERITONEAL DIALYSATE

MMB - HEARING-AID, TYMPANIC MEMBRANE

MAGNET
MNF - IMPLANT, TEMPORAL

Not
Classified
2

N
N

Y
Y

MNH - ORTHOSIS, SPONDYLOLISTHESIS SPINAL

FIXATION

MNI - ORTHOSIS, SPINAL PEDICLE FIXATION

MNT - VENTILATOR, CONTINUOUS, MINIMAL

VENTILATORY SUPPORT,FACILITY USE
MNU - STAPLE, ABSORBABLE

2
2

Y
N

N
Y

MOO - ORTHOPEDIC IMPLANT MATERIAL

Unclassified

MOP - ROTATOR, PROSTHETIC HEART VALVE

Unclassified

MPB - CATHETER, HEMODIALYSIS, NONIMPLANTED

MPD - AUXILLARY POWER SUPPLY (AC OR DC)

FOR LOW-ENERGY DC-DEFIBRILLATOR

MPE - AUXILLARY POWER SUPPLY (AC OR DC)

FOR EXTERNAL TRANSCUTANEOUS CARDIAC
PACEMAKER

MQN - EXTERNAL MANDIBULAR FIXATOR AND/OR

DISTRACTOR

15

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

MQO - PROSTHESTIC DISC NUCLEUS DEVICE

Not
Classified

MQP - SPINAL VERTEBRAL BODY REPLACEMENT

DEVICE

MQR - STENT, COLONIC, METALIC, EXPANDABLE

MQS - SYSTEM, HEMODIALYSIS, ACCESS

RECIRCULATION MONITORING
MQU - OCULAR PEG

2
2

Y
N

N
Y

MQV - FILLER, BONE VOID, CALCIUM COMPOUND

MQY - DOWEL, SMALL JOINT, BONE FUSION

Not
Classified

MRN - APPARATUS, NITRIC OXIDE DELIVERY

MRO - APPARATUS, NITRIC OXIDE, BACKUP

DELIVERY
MRP - ANALYZER, NITRIC OXIDE

2
2

Y
Y

N
N

MRQ - ANALYZER, NITROGEN DIOXIDE

MRW - SYSTEM, FACET SCREW SPINAL DEVICE

Unclassified

MRY - APPLIANCES AND ACCESSORIES, FIXATION,

BONE, ABSORBABLE SINGLE/MULTIPLE
COMPONENT

Unclassified

MSE - HEMODIALYZER, RE-USE, LOW FLUX

MSF - HEMODIALYZER, RE-USE, HIGH FLUX

MSK - IMMUNOASSAY FOR BLOOD TACROLIMUS

Not
Classified

MSX - SYSTEM,NETWORK AND

COMMUNICATION,PHYSIOLOGICAL MONITORS
MTJ - WAX,BONE
MTZ - WRAP, IMPLANT, ORBITAL

2
Unclassified
2

Y
N
N

N
Y
Y

MUF - SYSTEM,JOINT
RESTORATION,ARTHROSCOPICALLY DIRECTED

Not
Classified

MUM - STENT,METALLIC,EXPANDABLE,DUODENAL

MUV - STIMULATOR, VAGUS NERVE, IMPLANTED,

TREMOR

Not
Classified

16

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

MUY - STIMULATOR,VAGUS NERVE,

IMPLANTED,(COMA AND VEGETATIVE STATE)

Not
Classified

MVB - FILLER, BONE VOID, MEDICATED

Not
Classified

MWX - SYSTEM,PROSTATE,MAGNETIC/THERMAL
RODS

Not
Classified

MXC - RECORDER,EVENT,IMPLANTABLE
CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)

MXD - RECORDER,EVENT,IMPLANTABLE
CARDIAC,(WITH ARRHYTHMIA DETECTION)

MXW - SUTURE, SURGICAL, NONABSORBABLE,

POLY (VINYLIDENE FLUORIDE)

MXX - GEL,CAPSULAR CONTRACTURE

REDUCTION

Not
Classified

MYV - SCREW,ODONTIOD

2
Not
Classified

MZQ - BALLOON,DETACHABLE,FOR
NEUROVASCULAR OCCLUSION

MZT - DEVICE,HEIMLICH MANEUVER ASSIST

MZZ - PROSTHESIS, FEMORAL NAIL

Not
Classified

NAJ - AGENTS,EMBOLIC,FOR TREATMENT OF

UTERINE FIBROIDS

NAP - CARDIAC SUPPORT MESH WRAP

Not
Classified

MYU - ACCESSORY,BARIUM SULFATE,METHYL

METHACRYLATE FOR CRANIOPLASTY

NAR - STIMULATOR,PERIPHERAL
NERVE,IMPLANTED (PAIN RELIEF,OCCIPITAL
HEADACHE)
NBF - PROSTHESIS,RETINAL

Not
Classified
Not
Classified

NBI - CATHETER,INTRAVASCULAR,COOLING

Not
Classified

17

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

NBM - VENTILATOR,AUTOMATIC
CONTROLLER,PERCENT OXYGEN

Not
Classified

NBQ - STIMULATOR,VAGUS
NERVE,IMPLANTED,MYOCLONUS

Not
Classified

NBY - SUTURE, SURGICAL, NONABSORBABLE,

EXPANDED, POLYTETRAFLOUROETHYLENE

NCA - CLIP, IMPLANTABLE, FOR CORONARY

ARTERY BYPASS GRAFT (CABG)

NCB - WEIGHTS, EYELID, IMPLANTABLE

Not
Classified

NCH - STIMULATOR, VAGUS NERVE, IMPLANTED,

FOR TREATMENT OF OBESITY

Not
Classified

NCN - PROSTHESIS, KNEE, JOINT,

PATELLOFEMORALTIBIAL, SEMI-CONSTRAINED,
CEMENTED, CERAMIC/POLYMER/METAL

Not
Classified

NDB - STIMULATOR, VAGUS NERVE, IMPLANTED,

FOR ANXIETY

Not
Classified

NDD - CERCLAGE, FIXATION, METALLIC

NDE - ROD, FIXATION, INTRAMEDULLARY AND

ACCESSORIES, METALLIC AND NON-COLLAPSIBLE

NDF - PLATE, FIXATION, BONE, NON-SPINAL,

METALLIC

NDG - WASHER, BOLT, NUT, NON-SPINAL,

METALLIC

NDH - NAIL, FIXATION, BONE, METALLIC

NDI - STAPLE, FIXATION, BONE, METALLIC

NDJ - SCREW, FIXATION, BONE, NON-SPINAL,

METALLIC

NDK - SYSTEM, EXTERNAL FIXATOR (WITH

METALLIC INVASIVE COMPONENTS)

NDL - PIN, FIXATION, SMOOTH, METALLIC

NDM - PIN, FIXATION, THREADED, METALLIC

NDN - CEMENT, BONE, VERTEBROPLASTY

18

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

NEA - CEMENT, EAR, NOSE AND THROAT

NEH - ANCHOR, FASCIAL

2
2

N
N

Y
Y

NEU - MARKER, RADIOGRAPHIC, IMPLANTABLE

NEW - SUTURE, SURGICAL, ABSORBABLE,

POLYDIOXANONE

NFK - KIT, REPAIR, CATHETER, HEMODIALYSIS

NFM - EXPANDER, TISSUE, ORBITAL

NFN - GUIDEWIRE, CORONARY, TOTAL

OCCLUSION

Not
Classified

NGV - SYSTEM, APPENDAGE CLOSURE, LEFT

ATRIAL

Not
Classified

NHA - ABUTMENT, IMPLANT, DENTAL,

ENDOSSEOUS

NHC - CATHETER, VENTRICULAR (CONTAINING

ANTIBIOTIC OR ANTIMICROBIAL AGENTS)

NHK - RESUSCITATOR,MANUAL,NON SELFINFLATING

NHR - MATERIAL, IMPLANT, UTERINE, FOR

ADHESIOGENIC EFFECT

Unclassified

NHW - ELECTRODE, PACING AND

CARDIOVERSION, TEMPORARY, EPICARDIAL

NIE - CATHETER, HEMODIALYSIS, TRIPLE LUMEN,

NON-IMPLANTED

NIX - HEARING AID, AIR CONDUCTION,

TRANSCUTANEOUS SYSTEM

NJA - ACCESSORY, SYSTEM, EXTERNAL FIXATOR,

CONTAINING ANTIMICROBIAL AGENT
NJC - CLIP, VAS DEFERENS

2
2

N
N

Y
Y

NJD - PROSTHESIS, KNEE, FEMOROTIBIAL, SEMICONSTRAINED,

UNICOMPARTMENTAL/UNICONDYLAR,
UNCEMENTED, POROUS-COATED,
METAL/POLYMER

NJU - SUTURE, NONABSORBABLE, NITINOL

19

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

NKG - ORTHOSIS, CERVICAL PEDICLE SCREW

SPINAL FIXATION

Unclassified

NKH - ORTHOSIS, PEDICLE SCREW SPINAL

SYSTEM, SPONDYLOSIS AND FACET
DEGENERATION

Not
Classified

NKL - MOLECULAR ADSORBENT RECIRCULATING

SYSTEM (MARS)

Unclassified

NKM - MITRAL VALVE REPAIR DEVICES

Not
Classified

NMA - TUBE, TRACHEAL, REPROCESSED

NMJ - CLIP, IMPLANTABLE, REPROCESSED

NOL - REAGENTS, RNA AMPLIFICATION, SARS

CORONAVIRUS

Not
Classified

NOU - CONTINUOUS, VENTILATOR, HOME USE

NOV - ANCHOR, SUTURE, BONE FIXATION,

METALLIC

NOY - AGENTS, EMBOLIC, FOR TREATMENT OF

BENIGN HYPERPLASIA

Not
Classified

NPF - MONITOR, APNEA, HOME USE

NPJ - PROSTHESIS, KNEE

PATELLOFEMOROTIBIAL, PARTIAL, SEMICONSTRAINED, CEMENTED,
POLYMER/METAL/POLYMER

NPK - BARRIER, SYNTHETIC, INTRAORAL

NPL - BARRIER, ANIMAL SOURCE, INTRAORAL

NPM - BONE GRAFTING MATERIAL, ANIMAL

SOURCE

NPU - PROSTHESIS, MITRAL VALVE,

PERCUTANEOUSLY DELIVERED

Not
Classified

NQB - CONFORMER, OPHTHALMIC, BIOLOGICAL

TISSUE

NQH - SENSOR, PRESSURE, ANEURYSM,

IMPLANTABLE

20

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

NQJ - CATHETER, HEMODIALYSIS, NONIMPLANTED, ULTRAFILTRATION, FOR PERIPHERAL

USE

NQP - POSTERIOR METAL/POLYMER SPINAL

SYSTEM, FUSION

NQW - ORTHOSIS, SPINE, PLATE, LAMINOPLASTY,

METAL

NRO - SURGICAL LIP IMPLANT

2
Not
Classified

NRV - IMPLANTABLE RADIO FREQUENCY

TRANSPONDER SYSTEM

NUD - VERTEBROPLASTY COMPOUND, CALCIUM

BASED

NUN - BONE GRAFTING MATERIAL, HUMAN

SOURCE

NVH - SUTURE, KNOT, MECHANICAL

NVR - INTERVERTEBRAL FUSION DEVICE WITH

BONE GRAFT, SOLID-SPHERE, LUMBAR

Unclassified

NVU - AGENT, VASCULAR, EMBOLIZATION, DRUGELUTING

Not
Classified

NWA - PROSTHESIS, TRACHEAL,

PREFORMED/MOLDED

NWJ - SUTURE, RECOMBINANT TECHNOLOGY

NXP - STENT, TIBIAL

2
Not
Classified

NXW - STENT, TIBIAL, ABSORBABLE

Not
Classified

NYT - PROSTHESIS, TRACHEAL, EXPANDABLE,

POLYMERIC

NZT - DOSIMETER, IONIZING RADIATION,

IMPLANTED

OAT - IMPLANT, ENDOSSEOUS, ORTHODONTIC

OBL - CEMENT, BONE, PRE-FORMED, MODULAR,

POLYMERIC, VERTEBROPLASTY

NQY - VENTILATOR, CONTINUOUS, MINIMAL

VENTILATORY SUPPORT, HOME USE

NXM - PROSTHESIS, EYELID SPACER/GRAFT,

BIOLOGIC

21

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

OBM - CEMENT, BONE, VERTEBROPLASTY, PREFORMED, MODULAR

OBT - PLATE, BONE, GROWTH CONTROL,

PEDIATRIC, EPIPHYSIODESIS

OCD - STIMULATOR, CERVICAL SPINAL CORD,

CEREBRAL VASOSPASM

Not
Classified

ODE - ENDOSCOPIC SUTURE/PLICATION SYSTEM,

GASTROESOPHAGEAL REFLUX DISEASE (GERD)

ODL - HYPERTENSION-THERAPY ELECTRICAL

NERVE STIMULATION SYSTEM

Not
Classified

ODM - NOCTURNAL DIALYSATE DELIVERY SYSTEM

Not
Classified

ODO - SORBENT REGENERATED NOCTURNAL

DIALYSATE DELIVERY SYSTEM

Not
Classified

ODP - INTERVERTEBRAL FUSION DEVICE WITH

BONE GRAFT, CERVICAL
ODU - FACIAL IMPLANT

2
2

N
N

Y
Y

OEW - TRACKING, SOFT TISSUE, INTRAOPERATIVE

OHA - HEART VALVE, MORE THAN MINIMALLY

MANIPULATED ALLOGRAFT

Unclassified

OIS - CALCIUM SALT BONE VOID FILLER,

DRILLABLE, NON-SCREW AUGMENTATION

OIY - PROSTHESIS, KNEE,

PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
CEMENTED, POLYMER +
ADDITIVE/METAL/POLYMER + ADDITIVE

OJB - RESORBABLE SPINAL INTERVERTEBRAL

BODY FIXATION ORTHOSIS - PLATE

OJM - RESORBABLE SPINAL INTERVERTEBRAL

BODY FIXATION ORTHOSIS - MESH

22

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

OKC - IMPLANTED SUBCUTANEOUS SECUREMENT

CATHETER

OKS - LACRIMAL STENTS AND INTUBATION SETS

Unclassified

OLB - DRUG-ELUTING INTERNAL PUDENDAL

ARTERY (IPA) AND HYPOGASTRIC ARTERY STENT

Not
Classified

OLC - SCAFFOLD, PARTIAL MEDIAL MENISCAL

DEFECTS EXTENDING INTO THE RED/WHITE
ZONE, RESORBABLE BOVINE COLLAGEN

OLL - SEPTAL STAPLER/ABSORBABLE STAPLES

OMF - PERCUTANEOUS, IMPLANTED, LONG-TERM

INTRAVASCULAR CATHETER ACCESSORY FOR
CATHETER POSITION

OMH - PERICARDIAL PATCH TO FACILITATE

REVISION SURGERIES
OMR - VESSEL GUARD OR COVER
OOD - SURGICAL FILM

2
2
2

Y
N
Y

Y
Y
Y

OOM - SUBTALAR JOINT-CROSSING UNCEMENTED

SEMI-CONSTRAINED ANKLE PROSTHESIS

Not
Classified

OPZ - PROSTHESIS, SHOULDER, NONTRADITIONAL STEM, SEMI-CONSTRAINED,

METAL/POLYMER, UNCEMENTED

OQG - HIP PROSTHESIS, SEMI-CONSTRAINED,

CEMENTED, METAL/POLYMER, + ADDITIVE,
POROUS, UNCEMENTED

OQH - HIP, SEMI-CONSTRAINED, CEMENTED,

METAL/POLYMER + ADDITIVE, CEMENTED

OQI - HIP, SEMI-CONSTRAINED, CEMENTED,

METAL/CERAMIC/POLYMER + ADDITIVE, POROUS
UNCEMENTED

ORY - PRELUDE TONGUE SUSPENSION SYSTEM

OSH - PEDICLE SCREW SPINAL SYSTEM,

ADOLESCENT IDIOPATHIC SCOLIOSIS

23

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

OSN - SOFTWARE FOR DIAGNOSIS/TREATMENT

OSO - IN-SITU, POLYMER, BONE FIXATION

Not
Classified

OST - IN UTERO FETAL TRACHEAL OCCLUSION

DEVICE, DETACHABLE BALLOON AND DELIVERY
SYSTEM

Not
Classified

OTD - ENDOVASCULAR SUTURING SYSTEM

OTM - MESH, SURGICAL, FOR STRESS URINARY

INCONTINENCE, MALE

OTN - MESH, SURGICAL, SYNTHETIC,

UROGYNECOLOGIC, FOR STRESS URINARY
INCONTINENCE, FEMALE, MULTI-INCISION

OTO - MESH, SURGICAL, SYNTHETIC,

UROGYNECOLOGIC, FOR APICAL VAGINAL AND
UTERINE PROLAPSE, TRANSABDOMINALLY
PLACED

OTP - MESH, SURGICAL, SYNTHETIC,

UROGYNECOLOGIC, FOR PELVIC ORGAN
PROLAPSE, TRANSVAGINALLY PLACED
OUR - SACROILIAC JOINT FIXATION

2
2

N
N

Y
Y

OVD - INTERVERTEBRAL FUSION DEVICE WITH

INTEGRATED FIXATION, LUMBAR

OVE - INTERVERTEBRAL FUSION DEVICE WITH

INTEGRATED FIXATION, CERVICAL

OVZ - PIN, FIXATION, RESORBABLE, HARD TISSUE

OWI - BONE FIXATION CERCLAGE, SUBLAMINAR

OWR - MESH, SURGICAL, NON-ABSORBABLE,

FACIAL IMPLANTS FOR PLASTIC SURGERY

OWS - MESH, SURGICAL, COLLAGEN, PLASTICS,

FACIAL IMPLANTS

OWT - MESH, SURGICAL, ABSORBABLE,

ABDOMINAL HERNIA

24

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

OWU - MESH, SURGICAL, NON-ABSORBABLE,

DIAPHRAGMATIC HERNIA

OWV - MESH, SURGICAL, COLLAGEN,

DIAPHRAGMATIC HERNIA

OWW - MESH, SURGICAL, ABSORBABLE,

ORTHOPAEDICS, REINFORCEMENT OF TENDON

OWX - MESH, SURGICAL, NON-ABSORBABLE,

ORTHOPAEDICS, REINFORCEMENT OF TENDON

OWY - MESH, SURGICAL, COLLAGEN,

ORTHOPAEDICS, REINFORCEMENT OF TENDON

OWZ - MESH, SURGICAL, ABSORBABLE,

THORACIC, CHEST WALL RECONSTRUCTION

OXA - MESH, SURGICAL, NON-ABSORBABLE,

THORACIC, CHEST WALL RECONSTRUCTION

OXB - MESH, SURGICAL, COLLAGEN, THORACIC,

CHEST WALL RECONSTRUCTION

OXC - MESH, SURGICAL, ABSORBABLE, STAPLE

LINE REINFORCEMENT

OXD - MESH, SURGICAL, NON-ABSORBABLE,

STAPLE LINE REINFORCEMENT

OXE - MESH, SURGICAL, COLLAGEN, STAPLE LINE

REINFORCEMENT

OXF - MESH, SURGICAL, ABSORBABLE, PLASTIC

AND RECONSTRUCTIVE SURGERY

OXG - MESH, SURGICAL, NON-ABSORBABLE,

PLASTIC AND RECONSTRUCTIVE SURGERY

OXH - MESH, SURGICAL, COLLAGEN, PLASTIC AND

RECONSTRUCTIVE SURGERY

OXI - MESH, SURGICAL, ABSORBABLE, LARGE

ABDOMINAL WALL DEFECTS

25

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

OXJ - MESH, SURGICAL, NON-ABSORBABLE,

LARGE ABDOMINAL WALL DEFECTS

OXK - MESH, SURGICAL, COLLAGEN, LARGE

ABDOMINAL WALL DEFECTS

OXL - MESH, SURGICAL, ABSORBABLE, ORGAN

SUPPORT

OXM - MESH, SURGICAL, ABSORBABLE, FISTULA

OXN - MESH, SURGICAL, COLLAGEN, FISTULA

OYR - FILLER, BONE VOID, RECOMBINANT

PLATELET-DERIVED GROWTH FACTOR

Not
Classified

OZI - INTERNAL HINGED ELBOW FIXATOR

Not
Classified

OZS - PRESSURE, FLUID REMOVAL, FASCIOTOMY,

INTRACOMPARTMENTAL

Not
Classified

PAG - MESH, SURGICAL, NON-SYNTHETIC,

UROGYNECOLOGIC, FOR STRESS URINARY
INCONTINENCE, FEMALE, MULTI-INCISION

PAH - MESH, SURGICAL, SYNTHETIC,

UROGYNECOLOGIC, FOR STRESS URINARY
INCONTINENCE, FEMALE, SINGLE-INCISION MINISLING

PAI - MESH, SURGICAL, NON-SYNTHETIC,

UROGYNECOLOGIC, FOR PELVIC ORGAN
PROLAPSE, TRANSVAGINALLY PLACED

PAJ - MESH, SURGICAL, NON-SYNTHETIC,

UROGYNECOLOGIC, FOR APICAL VAGINAL AND
UTERINE PROLAPSE, TRANSABDOMINALLY
PLACED

PAO - PROSTHESIS, SHOULDER, SEMICONSTRAINED, METAL/POLYMER + ADDITIVE,

CEMENTED

26

List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

PAW - NONABSORBABLE EXPANDED

POLYTETRAFLUOROETHYLENE SURGICAL
SUTURE FOR CHORDAE TENDINAE REPAIR OR
REPLACEMENT

PBI - PROSTHESIS, HIP, CONSTRAINED,

CEMENTED OR UNCEMENTED, METAL/POLYMER,
+ ADDITIVE

PBJ - CRANIAL DISTRACTION SYSTEM

PBQ - FIXATION, NON-ABSORBABLE, FOR PELVIC

USE

PBU - BONE VOID FILLER, SYRINGE

Not
Classified

27