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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 NumberS005
Date Received11/26/1996
Decision Date05/12/1997
Withdrawal Date 06/30/2009
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MODIFIED VERSION OF THE ORIGINAL GIANTURCO-ROUBIN CORONARY FLEX STENT(TM). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GR II(TM) CORONARY STENT AND IS INDICATED FOR TREATMENT OF ACUTE OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN VESSELS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.1 MM TO 4.0 MM.
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