Ranger™ Paclitaxel-Coated PTA Balloon Catheter

FDA premarket approval P190019 · Drug-Eluting Peripheral Transluminal Angioplasty Catheter

PMA numberP190019

Approval

Applicant
Boston Scientific Corporation
Received
July 22, 2019
Decision date
October 30, 2020 (APPR)
Supplements
41, latest August 4, 2026
Product code
ONU – Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Official FDA PMA record

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.