|
Device | ORSIRO Sirolimus Eluting Coronary Stent System, ORSIRO Mission 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 | S019 |
Date Received | 08/03/2021 |
Decision Date | 02/18/2022 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the introduction of semi-automated optimized spray coating equipment and additional stent holders for the drug coating process |