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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
Applicant
Biotronik, Inc
6024 jean road
lake oswego, OR 97035
PMA NumberP170030
Supplement NumberS018
Date Received07/02/2021
Decision Date07/28/2021
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Changes to the stability study parameters and the introduction of a leak test method for packaging integrity testing.
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