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. |
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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 | S002 |
Date Received | 05/19/2022 |
Decision Date | 06/16/2022 |
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 Implementation of a new in-process inspection step, new equipment for aeration and new colorant resin for a component of the delivery system of the Thoraflex Hybrid device. |
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