- Device
- IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S071
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2022-12-01
- Decision code
- OK30
- Date received
- 2022-11-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an alternative bacterial water testing method.