- Device
- Tack Endovascular System (4F)
- Applicant
- Philips Image Guided Therapy Corporation (Formerly Intact)
- PMA number
- P190027
- Supplement
- S004
- Product code
- QCT
- Generic name
- Scaffold, dissection repair
- Decision date
- 2022-05-24
- Decision code
- APPR
- Date received
- 2022-02-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change of quality management system and design ownership from Intact Vascular, Inc. to Philips Image Guided Therapy Corporation.