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 vascular complete se vascular stent system. This device is indicated to improve luminal diameter in symptomatic patients with de novo and/or restenotic lesions or occlusions of the superficial femoral artery (sfa) or proximal popliteal artery (ppa) with reference diameters ranging from 4 mm to 7 mm and lesion lengths up to 140 mm.
| Device | MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | Medtronic Vascular |
| Date Received | 2011-12-12 |
| Decision Date | 2013-09-19 |
| Notice Date | 2013-09-23 |
| PMA | P110040 |
| Supplement | S |
| Product Code | NIP |
| Docket Number | 13M-1159 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110040 | Original Filing | |
| S011 | 2016-08-17 | 135 Review Track For 30-day Notice |
| S010 | 2016-07-13 | 30-day Notice |
| S009 | 2016-05-05 | 30-day Notice |
| S008 | 2015-09-24 | 30-day Notice |
| S007 | 2015-06-15 | Normal 180 Day Track No User Fee |
| S006 | 2015-03-20 | 135 Review Track For 30-day Notice |
| S005 | 2014-03-04 | 30-day Notice |
| S004 | 2014-01-30 | 30-day Notice |
| S003 | 2014-01-09 | 30-day Notice |
| S002 | 2013-12-16 | 30-day Notice |
| S001 | 2013-11-01 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00643169150829 | P110040 | 000 |
| 00643169150645 | P110040 | 000 |
| 00643169150652 | P110040 | 000 |
| 00643169150669 | P110040 | 000 |
| 00643169150676 | P110040 | 000 |
| 00643169150737 | P110040 | 000 |
| 00643169150744 | P110040 | 000 |
| 00643169150751 | P110040 | 000 |
| 00643169150768 | P110040 | 000 |
| 00643169150775 | P110040 | 000 |
| 00643169150782 | P110040 | 000 |
| 00643169150799 | P110040 | 000 |
| 00643169150805 | P110040 | 000 |
| 00643169150812 | P110040 | 000 |
| 00643169150638 | P110040 | 000 |