Approval for updated in-process sampling requirements and to remove redundant inspections.
| Device | COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | Medtronic Vascular |
| Date Received | 2016-08-17 |
| Decision Date | 2017-02-01 |
| PMA | P110040 |
| Supplement | S011 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403 |
Supplemental Filings
| 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 |
NIH GUDID Devices