Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
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 | S004 |
Date Received | 04/28/2023 |
Decision Date | 05/26/2023 |
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 Increase the number of Thoraflex Hybrid device samples that undergo the elevated aeration step at a time. |
|
|