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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 NumberS016
Date Received12/30/2025
Decision Date01/29/2026
Product Code QSK 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
an update to the lFU to include additional language regarding early imaging surveillance for patients at risk for intraluminal thrombosis
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