OEPAR'TMENi 0FHEALTH & HuMAN SERViCES

Food aiJd·Drug Administration

9200 CQrporateBOUleY<lfd
Rockville, Maryland 20850

NOV 26 ZOUd

Dean M. Harrison
President and CEO
Northwestern Memorial Healthcare
251 East Huron Stre.et
Chicago f IL 60611

DearMt. Harrison;

ThepurpO$e of this letteri~ to discuss the"Po()dand-Dru,g Administratidn (FDA)

inspection oftheNorthweste.m.University lnstltunonalReview Board (IRB) conducted
on August 8,2008. The inspection was Gonducted by an investi~tor from FDA's
Chicago District Office and was focuse.d on Dr. Patrick McCarthy's OUtcome registry and
the Edwards Lifesciences, LLC, Myxo Etlogix annuloplasty ring. In order to ensure
appropriate notification of subjects, FDA suggests you contact Edwards Lifes~iences,
LLC to ascertain if this outcome registry data was used in an application to the Agency.
No response to this letter is necessary at this time.

We appreciate thecoiJrtesy and cooperation extended to the FDA investigator during the
inspection. You may find information conceming the device Bioresearch Monitoring
program at our Internet homepage, http://www.fda.gov/cdrhlcomplbimo.html. Valuable
links to related information are also included at this site. If you have any questions, do
not hesitate
.
to contact Catherine. Parker at (240) 276·0125.

Sincerely yourSj

. . /h...; .'.~.
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~....... ....
.. . . ..
' ' .'. . . .... .. ' ....... ....
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Doreen Ke-zer. MSN) . .

Chief,Speciai Investigations Branch
Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and
Radiological Health

"REGULATORYAFFAtRS

EDWARDS CONFIDENTIAL. PROVIDED PURSUANT TO SENATE RULE XXIX. EW-S-20000001

 Page 2 - Dean M. Harrison

cc:
Ms, Debra Gibson Tice
Interim Director ofJRBOperations
Northwestern University IRB
750 N Lake Shore Drive, 7th Floor
Chicago, IL 60611

Scott Beggins
Vice President, Regulatory Affairs
Edwards Lifesciences LLC
One Edwards Way
Irvine, Ca 92614

Martin A. Kauftnan. RAe

Direytor, Reglll~tory Affairs
Edwards LifesciencesLLC
One Edwards Way
Irvine. ea 92614

REGULATORY AFFAIRS

EDWARDS CONFIDENTIAL. PROVIDED PURSUANT TO SENATE RULE XXIX. EW-S-20000002