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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 NumberS015
Date Received09/30/2025
Decision Date10/29/2025
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  
removal of select incoming inspection steps and select incoming goods bioburden monitoring procedures for the Thoraflex™ Hybrid device
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