- Device
- IN.PACT Admiral Paclitaxelcoated PTA Balloon Catheter; IN.PACT 018 Paclitaxel-coated PTA Balloon Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S100
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2025-09-16
- Decision code
- OK30
- Date received
- 2025-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the laser-etching software for etching luer components