PMA P140010S106

Device: IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S106
Product code: ONU
Decision date: 2026-09-24
Classification: Cardiovascular
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: approval for a change to the in-process testing strategy and sample size for balloon burst testing, proximal weld tensile strength testing, and distal tip weld tensile of the IN.PACT DCB 018 catheter

Current openFDA PMA Record#

Device: IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S106
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2026-09-24
Decision code: OK30
Date received: 2026-09-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a change to the in-process testing strategy and sample size for balloon burst testing, proximal weld tensile strength testing, and distal tip weld tensile of the IN.PACT DCB 018 catheter