GORE TAG Thoracic Branch Endoprosthesis (TBE )

FDA Premarket Approval P210032

Pre-market Approval Supplement Details

DeviceGORE TAG Thoracic Branch Endoprosthesis (TBE )
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantW. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Date Received08/24/2021 Decision Date05/13/2022 Product Code MIH  Advisory Committee Cardiovascular Clinical TrialsNCT02777593 Expedited Review Granted? No
Date Received2021-08-24
Decision Date2022-05-13
PMAP210032
SupplementS
Product CodeMIH 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination ProductYes
Applicant AddressW. L. Gore & Associates, Inc.
3450 West Kiltie Lane
flagstaff, AZ 86005 PMA NumberP210032 Date Received08/24/2021 Decision Date05/13/2022 Product Code MIH  Advisory Committee Cardiovascular Clinical TrialsNCT02777593
Expedited Review Granted? No Combination ProductYes Approval Order Statement  
Approval For The GORE® TAG® Thoracic Branch Endoprosthesis. The Device Is Intended For Endovascular Repair Of Lesions Of The Descending Thoracic Aorta, While Maintaining Flow Into The Left Subclavian Artery, In Patients Who Are At High Risk For Debranching Subclavian Procedures. Supplements:  

Supplemental Filings

Supplement NumberDateSupplement Type
P210032Original Filing
S005 2022-12-15 30-day Notice
S004 2022-09-06 30-day Notice
S003 2022-07-26 30-day Notice
S002 2022-06-22 30-day Notice
S001 2022-06-09 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
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