- Device
- IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S053
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2021-12-17
- Decision code
- APPR
- Date received
- 2020-10-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a modified sampling plan for drug content uniformity testing.