|
Device | Thoraflex Hybrid |
Generic Name | Hybrid stent graft, thoracic aortic lesion treatment |
Applicant | Vascutek Ltd. Newmains Avenue Inchinnan PA4 9 |
PMA Number | P210006 |
Supplement Number | S001 |
Date Received | 05/18/2022 |
Decision Date | 08/08/2022 |
Product Code |
QSK |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02724072
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the protocol for the post-approval study (PAS) protocol. |