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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 NumberS042
Date Received03/25/2026
Decision Date04/24/2026
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  
updates to the post-coating visual inspection procedures performed at Freudenberg Medical Hemoteq for the Ranger Paclitaxel-Coated PTA Balloon Catheter
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