PMA P140010

Device: IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PT A) Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S071
Product code: ONU
Decision date: 2026-05-28
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: transferring the balloon manufacturing process from Medtronic Ireland to Medtronic Mexico

Current openFDA PMA Record#

Device: IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PT A) Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S105
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2026-05-28
Decision code: OK30
Date received: 2026-05-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: transferring the balloon manufacturing process from Medtronic Ireland to Medtronic Mexico