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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 FLEX STENT/GRII(TM) CORONARY STENT
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantCOOK, INC.
PMA NumberP910030
Supplement NumberS009
Date Received06/13/2000
Decision Date02/13/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: packager
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at cook, inc. , bloomington, indiana. Packaging of the devices will take place at this facility.
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