Tack Endovascular System (6F)
FDA premarket approval P180034/S005 · decided 2021-09-07
Approval details
- PMA number
- P180034
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Tack Endovascular System (6F)
- Generic name
- Scaffold, dissection repair
- Applicant
- Philips Image Guided Therapy Corporation
- Date received
- 2021-06-10
- Decision date
- 2021-09-07
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- QCT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for the labeling updates which incorporate the final 36-month results from the TOBA II Post Approval Study.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IntraSight Plus (K253714) | Philips Image Guided Therapy Corporation | 2026-02-24 |
| VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) (K251103) | Philips Image Guided Therapy Corporation | 2025-05-09 |
| VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter (K200812) | Philips Image Guided Therapy Corporation | 2020-09-02 |
| Reconnaissance PV .018 OTW Digital IVUS Catheter (K200410) | Philips Image Guided Therapy Corporation | 2020-05-22 |