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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 NumberS012
Date Received03/10/2025
Decision Date04/09/2025
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  
changes to the bioburden and cleanroom monitoring processes and addition of a new manufacturing equipment for the Thoraflex Hybrid
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