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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceThoraflex™ Hybrid
Generic NameHybrid stent graft, thoracic aortic lesion treatment
ApplicantVascutek, Ltd.
Newmains Ave.
Inchinnan PA49RR
PMA NumberP210006
Supplement NumberS007
Date Received12/15/2023
Decision Date01/11/2024
Product Code QSK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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
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