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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.
 
DeviceRanger Paclitaxel-Coated PTA Balloon Catheter
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantBoston Scientific Corporation
Three Scimed Pl.
Maple Grove, MN 55311
PMA NumberP190019
Supplement NumberS025
Date Received11/13/2023
Decision Date12/12/2023
Product Code ONU 
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  
changes to the sterilization Chamber 9 Programmable Logic Controller at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility
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