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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 AG
Ackerstrasse 6
Bülach 8180
PMA NumberP170030
Supplement NumberS066
Date Received08/25/2026
Decision Date09/24/2026
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
changes to solvent preparation and drug coating application
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