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 updated in-process sampling requirements and to remove redundant inspections.
| Device | COMPLETE SE VASCULAR STENT SYSTEM– ILIAC |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | Medtronic Vascular |
| Date Received | 2016-08-17 |
| Decision Date | 2017-02-01 |
| PMA | P090006 |
| Supplement | S019 |
| Product Code | NIO |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090006 | Original Filing | |
| S019 | 2016-08-17 | 135 Review Track For 30-day Notice |
| S018 | 2016-07-13 | 30-day Notice |
| S017 | 2016-05-05 | 30-day Notice |
| S016 | 2015-09-24 | 30-day Notice |
| S015 | 2015-03-20 | 135 Review Track For 30-day Notice |
| S014 | 2014-03-04 | 30-day Notice |
| S013 | 2014-01-09 | 30-day Notice |
| S012 | 2013-12-16 | 30-day Notice |
| S011 | 2013-09-16 | 30-day Notice |
| S010 | 2013-04-22 | 30-day Notice |
| S009 | 2013-03-11 | 135 Review Track For 30-day Notice |
| S008 | 2012-03-22 | 135 Review Track For 30-day Notice |
| S007 | 2011-08-08 | 30-day Notice |
| S006 | 2011-04-21 | 30-day Notice |
| S005 | 2011-03-01 | 30-day Notice |
| S004 | 2010-12-20 | 30-day Notice |
| S003 | 2010-11-26 | Normal 180 Day Track No User Fee |
| S002 | 2010-07-19 | Normal 180 Day Track |
| S001 |