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
• Generic Name: Coronary drug-eluting stent
• Applicant: Biotronik, Inc; 6024 Jean Road; Lake Oswego, OR 97035
• PMA Number: P170030
• Supplement Number: S010
• Date Received: 09/21/2020
• Decision Date: 10/21/2020
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Changes to the sirolimus impurities and chloroform residual testing methods.