PMA P140010S099

Device: IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S099
Product code: ONU
Decision date: 2025-08-12
Classification: Cardiovascular
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: transferring the balloon forming process from Medtronic Ireland to Medtronic Mexico for the IN.PACT 018 DCB

Current openFDA PMA Record#

Device: IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S099
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2025-08-12
Decision code: OK30
Date received: 2025-07-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: transferring the balloon forming process from Medtronic Ireland to Medtronic Mexico for the IN.PACT 018 DCB