Premarket Approval (PMA)

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.

• Device: Ranger™ Paclitaxel-Coated PTA Balloon Catheter
• Generic Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
• Applicant: Boston Scientific Corporation; Three Scimed Pl.; Maple Grove, MN 55311
• PMA Number: P190019
• Supplement Number: S024
• Date Received: 09/07/2023
• Decision Date: 09/22/2023
• Product Code: ONU
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol to shorten follow-up from 5 years to 3 years for the post-approval study (PAS) protocol.