PMA P140010S102

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter; IN.PACT 018 Paclitaxel-Coated
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S102
Product code: ONU
Decision date: 2026-04-23
Classification: Cardiovascular
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: the implementation of an ultraviolet (UV) filter in the water trough system

Current openFDA PMA Record#

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter; IN.PACT 018 Paclitaxel-Coated
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S102
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2026-04-23
Decision code: OK30
Date received: 2026-03-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the implementation of an ultraviolet (UV) filter in the water trough system