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 automation of an existing inspection process.
| Device | PRO-Kinetic Energy Coronary Stent System |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2018-06-29 |
| Decision Date | 2019-04-25 |
| PMA | P160003 |
| Supplement | S006 |
| Product Code | MAF |
| 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 | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160003 | Original Filing | |
| S015 | 2022-06-21 | 30-day Notice |
| S014 | 2021-06-14 | 30-day Notice |
| S013 | 2021-04-08 | 30-day Notice |
| S012 | 2021-03-25 | 30-day Notice |
| S011 | ||
| S010 | 2020-07-09 | 30-day Notice |
| S009 | 2019-11-04 | 30-day Notice |
| S008 | 2019-05-06 | 30-day Notice |
| S007 | ||
| S006 | 2018-06-29 | 135 Review Track For 30-day Notice |
| S005 | 2018-05-10 | Normal 180 Day Track No User Fee |
| S004 | 2018-04-16 | 30-day Notice |
| S003 | ||
| S002 | 2017-04-19 | 135 Review Track For 30-day Notice |
| S001 | 2017-02-22 | 30-day Notice |