- Device
- IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S051
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2020-10-05
- Decision code
- APPR
- Date received
- 2020-07-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a site change for packaging and labeling rework processes.