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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameGIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantCOOK, INC.
PMA NumberP910030
Date Received06/06/1991
Decision Date02/08/1993
Withdrawal Date 06/30/2009
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 93M-0212
Notice Date 07/22/1993
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S005 S008 S009 
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