PMA P140010S097

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S097
Product code: ONU
Decision date: 2025-08-12
Classification: Cardiovascular
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: reducing the filter size at the supplier for the Water for Injection (WFI) supplied to Medtronic and used in cleaning the temporary packaging aids (stylets) during the stylet preparation process

Current openFDA PMA Record#

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S097
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2025-08-12
Decision code: OK30
Date received: 2025-07-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: reducing the filter size at the supplier for the Water for Injection (WFI) supplied to Medtronic and used in cleaning the temporary packaging aids (stylets) during the stylet preparation process