Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• 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
• Date Received: 07/22/2019
• Decision Date: 10/30/2020
• Product Code: ONU
• Docket Number: 20M-2152
• Notice Date: 11/02/2020
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT03064126
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the Ranger Paclitaxel-Coated PTA Balloon Catheter. This device is indicated for percutaneous transluminal angioplasty (PTA) of de novo or restenotic lesions up to 180 mm in length located in native superficial femoral and proximal popliteal arteries (SFA/PPA) with reference vessel diameters of 4 -7 mm.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S003 S004 S005 S019 S020 S009 S010 S011 S012 S013 S015 S016 ; S017 S022 S023 S024 S030 S031 S032 S037 S038 S027 S028 ; S029 S041 S036 S042 S001 S002 S008 S040 S006 S007 S018 S014 ; S033 S039 S025 S026 S034