Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System
• Generic Name: Coronary drug-eluting stent
• Applicant: Biotronik AG; Ackerstrasse 6; Bülach 8180
• PMA Number: P170030
• Supplement Number: S022
• Date Received: 03/04/2022
• Decision Date: 08/31/2022
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the PMA Post-Approval Study Labeling Update for the Orsiro and Orsiro Mission Siolimus Eluting Coronary Stent Systems.