PMA P190019

Device: Ranger™ Paclitaxel-Coated Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P190019
Supplement: S017
Product code: ONU
Decision date: 2026-08-04
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
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.

Current openFDA PMA Record#

Device: Ranger™ Paclitaxel-Coated Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P190019
Supplement: S043
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2026-08-04
Decision code: APPR
Date received: 2026-05-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.