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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 Balloon Catheter
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantBoston Scientific Corporation
Three Scimed Pl.
Maple Grove, MN 55311
PMA NumberP190019
Supplement NumberS043
Date Received05/08/2026
Decision Date08/04/2026
Product Code ONU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a matrix expansion of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter (P190019) to include the Ranger 035™ Paclitaxel-Coated PTA Balloon Catheter, a 0.035-inch guidewire compatible line extension.
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