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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 Avenue
Inchinnan PA4 9
PMA NumberP210006
Supplement NumberS005
Date Received07/27/2023
Decision Date11/20/2023
Product Code QSK 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change in equipment used to manufacture the delivery system and a change in cleaning method for the stainless-steel shaft component of the delivery system.
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