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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceThoraflex™ Hybrid
Generic NameHybrid stent graft, thoracic aortic lesion treatment
ApplicantVascutek Ltd.
Newmains Avenue
Inchinnan PA4 9
PMA NumberP210006
Date Received02/25/2021
Decision Date04/19/2022
Product Code QSK 
Docket Number 22M-0632
Notice Date 04/21/2022
Advisory Committee Cardiovascular
Clinical TrialsNCT02724072
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Thoraflex Hybrid. The device is intended for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta in cases of aneurysm and/or dissection.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S006  S003 S007 S005 
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