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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
DeviceOrsiro Sirolimus Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantBiotronik, Inc
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP170030
Supplement NumberS012
Date Received10/16/2020
Decision Date11/13/2020
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Revisions to production documents and removal of specific process controls that are subsequently repeated during the manufacturing process.