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 implementation of a semi-automated passivation process and a change to the passivation of stent couplings by an alternate vendor.
| Device | SUPERA PERIPHERAL STENT SYSTEM |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) |
| Date Received | 2014-05-27 |
| Decision Date | 2014-07-10 |
| PMA | P120020 |
| Supplement | S004 |
| 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 | ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) 3200 Lakeside Drive santa Clara, CA 95054 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120020 | Original Filing | |
| S030 | 2022-11-21 | 135 Review Track For 30-day Notice |
| S029 | 2022-09-30 | Real-time Process |
| S028 | 2022-09-30 | Real-time Process |
| S027 | 2021-09-08 | 30-day Notice |
| S026 | 2021-01-05 | Normal 180 Day Track |
| S025 | 2020-11-24 | 30-day Notice |
| S024 | 2020-09-01 | 30-day Notice |
| S023 | 2019-05-16 | 30-day Notice |
| S022 | 2019-02-08 | 30-day Notice |
| S021 | 2019-01-24 | 30-day Notice |
| S020 | 2018-09-05 | 30-day Notice |
| S019 | 2018-08-24 | 30-day Notice |
| S018 | 2017-12-20 | Normal 180 Day Track |
| S017 | 2017-09-28 | 135 Review Track For 30-day Notice |
| S016 | 2017-06-14 | 30-day Notice |
| S015 | 2016-09-08 | 30-day Notice |
| S014 | 2016-08-30 | 135 Review Track For 30-day Notice |
| S013 | 2016-05-09 | Normal 180 Day Track No User Fee |
| S012 | 2015-11-24 | 30-day Notice |
| S011 | 2015-08-10 | Normal 180 Day Track No User Fee |
| S010 | 2015-05-11 | 30-day Notice |
| S009 | 2015-04-28 | Real-time Process |
| S008 | 2015-04-13 | 30-day Notice |
| S007 | 2015-02-05 | 30-day Notice |
| S006 | 2014-08-29 | Normal 180 Day Track No User Fee |
| S005 | 2014-08-05 | 30-day Notice |
| S004 | 2014-05-27 | 135 Review Track For 30-day Notice |
| S003 | 2014-05-22 | Normal 180 Day Track |
| S002 | 2014-04-08 | Normal 180 Day Track No User Fee |
| S001 | 2014-03-31 | Normal 180 Day Track No User Fee |