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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantCOOK, INC.
PMA NumberP910030
Supplement NumberS008
Date Received01/28/1998
Decision Date05/05/1998
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change in the instructions for use ("technical information and suggested instructions for placement") of the gr ii(tm) coronary stent.
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