|
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 | S028 |
Date Received | 03/31/2023 |
Decision Date | 12/21/2023 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement approval for an update to the specification for the maximum post-dilatation diameter for the T6S stent design from 3.5 mm to 4.0 mm |