PMA P140010S092

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S092
Product code: ONU
Decision date: 2025-05-29
Classification: Cardiovascular
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: changes to the sterilization process control computer and sterilization monitoring procedures

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: S092
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2025-05-29
Decision code: OK30
Date received: 2025-05-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the sterilization process control computer and sterilization monitoring procedures