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 medtronic wiktor(r) prime coronary stent delivery 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 graft vessels with reference diameters in the range of 3. 0 to 4. 5 mm.
| Device | MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM |
| Generic Name | Stent, Coronary |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR |
| Date Received | 1996-05-01 |
| Decision Date | 1997-06-27 |
| Notice Date | 1998-09-09 |
| PMA | P960010 |
| Supplement | S |
| Product Code | MAF |
| Docket Number | 98M-0726 |
| Advisory Committee | Cardiovascular |
| 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 |