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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.
 
DevicePromus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP110010
Supplement NumberS204
Date Received08/09/2022
Decision Date09/01/2022
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Introducing automated equipment for packaging, sealing, and inspection of the inner pack for PROMUS products in the drug eluting stent production unit.
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