|
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 | S007 |
Date Received | 12/15/2023 |
Decision Date | 01/11/2024 |
Product Code |
QSK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement a change in the storage location of the sub-assemblies and a change in the detergent used in the manufacturing of the Thoraflex Hybrid device |