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. |
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Device | GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG |
Generic Name | STENT, CORONARY |
Applicant | COOK, INC. P.O. BOX 489 BLOOMINGTON, IN 47402 |
PMA Number | P910030 |
Supplement Number | S008 |
Date Received | 01/28/1998 |
Decision Date | 05/05/1998 |
Withdrawal Date
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06/30/2009 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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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