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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 Everolimus-Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP110010
Supplement NumberS188
Date Received01/27/2021
Decision Date02/24/2021
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  
Adoption of the Ranger Paclitaxel-Coated PTA Balloon Catheter and Promus Everolimus-Eluting Coronary Stent System into the reduced EO gas concentration version of the BSC2000-2 sterilization cycle previously approved to sterilize other Boston Scientific Corporation (BSC) products.
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