This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the formula balloon- expandable renal stent system. This device is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (ptra) of a de novo or restenotic lesion (= 50% residual stenosis, >= 20 mmhg systolic or >= 10 mmhg mean translesional pressure gradient, or flow-limiting dissection.
| Device | FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM |
| Generic Name | Stent, Renal |
| Applicant | COOK MEDICAL INCORPORATED |
| Date Received | 2010-07-19 |
| Decision Date | 2011-01-14 |
| Notice Date | 2011-01-26 |
| PMA | P100028 |
| Supplement | S |
| Product Code | NIN |
| Docket Number | 11M-0056 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOK MEDICAL INCORPORATED 750 Daniels Way p.o. Box 489 bloomington, IN 47402-0489 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |