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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
Applicant
Biotronik, Inc
6024 jean road
lake oswego, OR 97035
PMA NumberP170030
Supplement NumberS007
Date Received07/08/2020
Decision Date06/24/2021
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a modified stent delivery system containing multiple material and design changes including an updated hub/luer connector, packaging changes to accommodate the modified stent delivery system, and a change to the stent crimping manufacturing process.
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