PMA P140010S103

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S103
Product code: ONU
Decision date: 2026-05-01
Classification: Cardiovascular
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: updates to the luer adhesive curing and balloon forming manufacturing processes

Current openFDA PMA Record#

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S103
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2026-05-01
Decision code: OK30
Date received: 2026-04-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to the luer adhesive curing and balloon forming manufacturing processes