PMA P140010S098

Device: IN.PACT™ 018 Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S098
Product code: ONU
Decision date: 2026-03-06
Classification: Cardiovascular
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: addition of 200 mm and 250 mm balloon lengths to the commercially available IN.PACT 018 Paclitaxel-coated PTA Balloon Catheter size matrix

Current openFDA PMA Record#

Device: IN.PACT™ 018 Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S098
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2026-03-06
Decision code: APPR
Date received: 2025-07-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: addition of 200 mm and 250 mm balloon lengths to the commercially available IN.PACT 018 Paclitaxel-coated PTA Balloon Catheter size matrix