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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, Orsiro Sirolimus Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantBiotronik AG
Ackerstrasse 6
Bülach 8180
PMA NumberP170030
Supplement NumberS023
Date Received05/12/2022
Decision Date03/22/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an update to the specification for the maximum allowed post-dilatation diameter for the 3.5 mm and 4.0 mm stent designs from 4.5 mm to 5.0 mm and updates to the dual antiplatelet therapy recommendation in the Instructions for Use for both the Orsiro and Orsiro Mission Stent Systems.
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