PMA P140010S089
- Device
- IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitaxe
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S089
- Product code
- ONU
- Decision date
- 2025-03-14
- Classification
- Cardiovascular
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- modified annual stability sampling plan
Current openFDA PMA Record#
- Device
- IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitaxe
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S089
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2025-03-14
- Decision code
- OK30
- Date received
- 2025-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modified annual stability sampling plan