| Device | Thoraflex™ Hybrid |
| Generic Name | Hybrid Stent Graft, Thoracic Aortic Lesion Treatment |
| Applicant | Vascutek Ltd.newmains Avenueinchinnan PA4 9 PMA NumberP210006 Date Received02/25/2021 Decision Date04/19/2022 Product Code QSK Advisory Committee Cardiovascular Clinical TrialsNCT02724072 Expedited Review Granted? No |
| Date Received | 2021-02-25 |
| Decision Date | 2022-04-19 |
| PMA | P210006 |
| Supplement | S |
| Product Code | QSK |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Vascutek Ltd. newmains Avenue inchinnan PA4 9 PMA NumberP210006 Date Received02/25/2021 Decision Date04/19/2022 Product Code QSK Advisory Committee Cardiovascular Clinical TrialsNCT02724072 Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For The Thoraflex Hybrid. The Device Is Intended For The Open Surgical Repair Or Replacement Of Damaged Or Diseased Vessels Of The Aortic Arch And Descending Aorta With Or Without Involvement Of The Ascending Aorta In Cases Of Aneurysm And/or Dissection. Approval OrderApproval Order SummarySummary Of Safety And Effectiveness LabelingLabeling Supplements: |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210006 | Original Filing | |
| S003 | 2022-07-01 | Real-time Process |
| S002 | 2022-05-19 | 30-day Notice |
| S001 |