This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the pro-kinetic energy cobalt chromium (cocr) coronary stent system. This device is indicated for improving coronary luminal diameter in patients with de novo or restenotic lesions in native coronary arteries with a reference vessel diameter ranging from 2. 25 mm to 4. 0 mm and lesion length
| Device | PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2016-01-19 |
| Decision Date | 2017-02-14 |
| Notice Date | 2017-02-17 |
| PMA | P160003 |
| Supplement | S |
| Product Code | MAF |
| Docket Number | 16M-2652 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |