- Device
- IN.PACT Admiral DCB Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S060
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2021-05-21
- Decision code
- APPR
- Date received
- 2021-04-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.