Tack Endovascular System (4F)
FDA premarket approval P190027/S004 · decided 2022-05-24
Approval details
- PMA number
- P190027
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Tack Endovascular System (4F)
- Generic name
- Scaffold, dissection repair
- Applicant
- Philips Image Guided Therapy Corporation (Formerly Intact)
- Date received
- 2022-02-23
- Decision date
- 2022-05-24
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- QCT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for a change of quality management system and design ownership from Intact Vascular, Inc. to Philips Image Guided Therapy Corporation.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.