- Device
- IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S067
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2022-09-02
- Decision code
- OK30
- Date received
- 2022-08-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an electronic Manufacturing Execution System (MES) to replace the current paper-based device history record (DHR).