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 | FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM |
Generic Name | STENT, RENAL |
Applicant | COOK MEDICAL INCORPORATED 750 DANIELS WAY P.O. BOX 489 BLOOMINGTON, IN 47402-0489 |
PMA Number | P100028 |
Supplement Number | S004 |
Date Received | 09/20/2013 |
Decision Date | 10/08/2014 |
Product Code |
NIN |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00631540
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Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING UPDATE BASED ON THE POST-APPROVAL STUDY RESULTS. |
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