Thoraflex™ Hybrid

FDA Premarket Approval P210006

Pre-market Approval Supplement Details

DeviceThoraflex™ Hybrid
Generic NameHybrid Stent Graft, Thoracic Aortic Lesion Treatment
ApplicantVascutek Ltd.newmains Avenueinchinnan PA4 9 PMA NumberP210006 Date Received02/25/2021 Decision Date04/19/2022 Product Code QSK  Advisory Committee Cardiovascular Clinical TrialsNCT02724072 Expedited Review Granted? No
Date Received2021-02-25
Decision Date2022-04-19
PMAP210006
SupplementS
Product CodeQSK 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination ProductNo
Applicant AddressVascutek Ltd.
newmains Avenue
inchinnan PA4 9 PMA NumberP210006 Date Received02/25/2021 Decision Date04/19/2022 Product Code QSK  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
Supplements:  

Supplemental Filings

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Supplement NumberDateSupplement Type
P210006Original Filing

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