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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 NumberS031
Date Received05/17/2024
Decision Date12/11/2024
Product Code ONU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modified labeling for the Ranger Paclitaxel-Coated PTA Balloon Catheter to reflect the long-term data from the Post-Approval Study
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