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 for the medtronic model 6322 wiktor(r) rival(tm) coronary stent system. This device is indicated for the treatment of abrupt or threatened closure in patients with failed interventional therapy in native coronary arteries and bypass grafts vessels with reference diameters in the range of 3. 0 to 4. 5mm.
| Device | MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM |
| Generic Name | Stent, Coronary |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR |
| Date Received | 1997-11-25 |
| Decision Date | 1998-05-21 |
| PMA | P960010 |
| Supplement | S001 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONICS INTERVENTIONAL VASCULAR 3576 Uno Cal Place santa Rosa, CA 95403 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960010 | Original Filing | |
| S001 | 1997-11-25 | Normal 180 Day Track |