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 to change the ethylene oxide (eo) sterilization release process for the affected products from using the traditional method of biological indicator testing to a parametric release process.
| 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 | 2017-09-28 |
| Decision Date | 2018-01-25 |
| PMA | P120020 |
| Supplement | S017 |
| 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 |