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Device | PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P160003 |
Date Received | 01/19/2016 |
Decision Date | 02/14/2017 |
Product Code |
MAF |
Docket Number | 16M-2652 |
Notice Date | 02/17/2017 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01612767
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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 <= 31 mm. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 |