- Device
- IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter; IN.PACT 018 Paclitaxel-Coated
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S104
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2026-05-21
- Decision code
- OK30
- Date received
- 2026-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a manufacturing line at the supplier to produce the IN.PACT Admiral header bag pouch