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-Over-The-Wire Paclitaxel Coated 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: S023
• Date Received: 09/07/2023
• Decision Date: 10/05/2023
• Product Code: ONU
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Introduce additional endotoxin test laboratories.