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.
Changes to the manufacturing equipment used in assembly of the complete se vascular stent system.
| Device | COMPLETE SE VASCULAR STENT SYSTEM- ILIAC |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | Medtronic Vascular |
| Date Received | 2015-09-24 |
| Decision Date | 2015-10-20 |
| PMA | P090006 |
| Supplement | S016 |
| Product Code | NIO |
| Advisory Committee | Cardiovascular |
| Supplement Type | 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 |