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.
Change to replace an extrusion machine used to produce various component tubes with a new extrusion machine.
| Device | Astron Pulsar/Pulsar-18 Stent Systems |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2018-04-16 |
| Decision Date | 2018-05-16 |
| PMA | P160025 |
| Supplement | S004 |
| Product Code | NIP |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 |
| 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 |