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.
| Device | Pulsar-18 Stent Systems |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS014 Date Received04/20/2022 Decision Date05/20/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-20 |
| Decision Date | 2022-05-20 |
| PMA | P160025 |
| Supplement | S014 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS014 Date Received04/20/2022 Decision Date05/20/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement increase In Laser Cutting Speed |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160025 | Original Filing | |
| S015 | 2022-06-21 | 30-day Notice |
| S014 | 2022-04-20 | 30-day Notice |
| S013 | ||
| S012 | 2021-09-15 | 30-day Notice |
| S011 | 2021-04-08 | 30-day Notice |
| S010 | 2021-03-25 | 30-day Notice |
| S009 | 2019-11-04 | 30-day Notice |
| S008 | 2019-07-15 | 30-day Notice |
| S007 | ||
| S006 | 2018-07-10 | 30-day Notice |
| S005 | 2018-06-21 | Normal 180 Day Track No User Fee |
| S004 | 2018-04-16 | 30-day Notice |
| S003 | 2017-10-11 | 30-day Notice |
| S002 | 2017-06-14 | Normal 180 Day Track No User Fee |
| S001 | 2017-04-19 | 135 Review Track For 30-day Notice |