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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 NumberS001
Date Received05/18/2022
Decision Date08/08/2022
Product Code QSK 
Advisory Committee Cardiovascular
Clinical TrialsNCT02724072
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) protocol.
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