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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 Mission Sirolimus Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantBiotronik AG
Ackerstrasse 6
Bülach 8180
PMA NumberP170030
Supplement NumberS051
Date Received01/28/2025
Decision Date04/11/2025
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the introduction of an additional wire position control and movability check during the guidewire exit port (GEP) welding and cutting manufacturing steps for the PK Papyrus Covered Coronary Stent System and the Orsiro Mission Sirolimus Eluting Coronary Stent System
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