- Device
- IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S095
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2025-07-09
- Decision code
- OK30
- Date received
- 2025-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of an alternate analytical HPLC column for the determination of urea in IN.PACT Admiral and IN.PACT AV paclitaxel coated PTA balloon catheters