Thoraflex Hybrid
FDA premarket approval P210006/S001 · decided 2022-08-08
Approval details
- PMA number
- P210006
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Thoraflex Hybrid
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Applicant
- Vascutek, Ltd.
- Date received
- 2022-05-18
- Decision date
- 2022-08-08
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- QSK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Inchinnan
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Gelweave™ Vascular Prostheses (K241550) | Vascutek, Ltd. | 2025-02-27 |
| Gelsoft™ Plus Vascular Prostheses (K241070) | Vascutek, Ltd. | 2024-11-15 |
| Vascutek Gelsoft Plus ERS Vascular Graft (K202703) | Vascutek, Ltd. | 2021-04-06 |
| Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (K200955) | Vascutek, Ltd. | 2020-07-08 |
| Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (K162803) | Vascutek, Ltd. | 2017-07-14 |
| Gelweave Vascular Grafts (K162794) | Vascutek, Ltd. | 2017-06-30 |
| GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS (K093817) | Vascutek, Ltd. | 2010-01-07 |
| MAXIFLO, TAPERFLO (K092863) | Vascutek, Ltd. | 2009-10-08 |