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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGIANTURCO-ROUBIN FLEX STENT/GRII(TM) CORONARY STENT
Generic NameSTENT, CORONARY
ApplicantCook, Inc.
P.O. Box 489
Bloomington, IN 47402
PMA NumberP910030
Supplement NumberS009
Date Received06/13/2000
Decision Date02/13/2002
Withdrawal Date06/30/2009
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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