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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 CORONARY FLEX-STENT(TM) 12MM LONG
Generic NameSTENT, CORONARY
ApplicantCook, Inc.
P.O. Box 489
Bloomington, IN 47402
PMA NumberP910030
Supplement NumberS008
Date Received01/28/1998
Decision Date05/05/1998
Withdrawal Date06/30/2009
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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