PMA P140010S096

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S096
Product code: ONU
Decision date: 2025-07-15
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 Admiral DCB and IN.PACT AV DCB

Current openFDA PMA Record#

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S096
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2025-07-15
Decision code: OK30
Date received: 2025-06-16
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 Admiral DCB and IN.PACT AV DCB