|
Device | ORSIRO Sirolimus Eluting Coronary Stent System |
Generic Name | Coronary drug-eluting stent |
Applicant | Biotronik, Inc 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P170030 |
Supplement Number | S011 |
Date Received | 10/02/2020 |
Decision Date | 10/30/2020 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval of the revised protocol for the post-approval study (PAS) protocol. |