Tack Endovascular System (4F, 1.5-4.5mm)
FDA premarket approval P190027/S005 · decided 2022-11-09
Approval details
- PMA number
- P190027
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Tack Endovascular System (4F, 1.5-4.5mm)
- Generic name
- Scaffold, dissection repair
- Applicant
- Philips Image Guided Therapy Corporation (Formerly Intact)
- Date received
- 2022-08-29
- Decision date
- 2022-11-09
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- QCT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for the post-approval labeling update to include the 36-month outcomes of the TOBA II BTK Post-Approval Study.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.