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.
Approval of the post-approval study protocol.
| Device | FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM |
| Generic Name | Stent, Renal |
| Applicant | COOK MEDICAL INCORPORATED |
| Date Received | 2011-10-06 |
| Decision Date | 2011-12-05 |
| PMA | P100028 |
| Supplement | S001 |
| Product Code | NIN |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOK MEDICAL INCORPORATED 750 Daniels Way p.o. Box 489 bloomington, IN 47402-0489 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100028 | Original Filing | |
| S004 | 2013-09-20 | Normal 180 Day Track No User Fee |
| S003 | 2013-01-28 | Normal 180 Day Track |
| S002 | 2012-02-13 | Real-time Process |
| S001 | 2011-10-06 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 10827002569758 | P100028 | 001 |
| 10827002569628 | P100028 | 001 |
| 10827002569611 | P100028 | 001 |
| 10827002569604 | P100028 | 001 |
| 10827002569598 | P100028 | 001 |
| 10827002569581 | P100028 | 001 |
| 10827002185286 | P100028 | 001 |
| 10827002185279 | P100028 | 001 |
| 10827002185262 | P100028 | 001 |
| 10827002185255 | P100028 | 001 |
| 10827002185248 | P100028 | 001 |
| 10827002569635 | P100028 | 001 |
| 10827002569642 | P100028 | 001 |
| 10827002569741 | P100028 | 001 |
| 10827002569734 | P100028 | 001 |
| 10827002569727 | P100028 | 001 |
| 10827002569710 | P100028 | 001 |
| 10827002569703 | P100028 | 001 |
| 10827002569697 | P100028 | 001 |
| 10827002569680 | P100028 | 001 |
| 10827002569673 | P100028 | 001 |
| 10827002569666 | P100028 | 001 |
| 10827002569659 | P100028 | 001 |
| 10827002185231 | P100028 | 001 |