|
Device | 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 | S025 |
Date Received | 06/23/2022 |
Decision Date | 01/26/2023 |
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 addition of an alternate supplier for the inner shaft component cIS7 |