GORE® TAG® Thoracic Branch Endoprosthesis

FDA Premarket Approval P210032 S001

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.

Pre-market Approval Supplement Details

DeviceGORE® TAG® Thoracic Branch Endoprosthesis
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantW. L. Gore & Associates, Inc.3450 West Kiltie Laneflagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS001 Date Received06/09/2022 Decision Date07/08/2022 Product Code MIH  Advisory Committee Cardiovascular Clinical TrialsNCT02777593 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-06-09
Decision Date2022-07-08
PMAP210032
SupplementS001
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductYes
Applicant AddressW. L. Gore & Associates, Inc.
3450 West Kiltie Lane
flagstaff, AZ 86005 PMA NumberP210032 Supplement NumberS001 Date Received06/09/2022 Decision Date07/08/2022 Product Code MIH  Advisory Committee Cardiovascular Clinical TrialsNCT02777593
Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductYes Approval Order Statement  
Approval Of The Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P210032.

Supplemental Filings

Supplement NumberDateSupplement Type
P210032Original Filing
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
00733132654116 P210032 000
00733132654239 P210032 000
00733132654246 P210032 000
00733132654253 P210032 000
00733132654260 P210032 000
00733132654277 P210032 000
00733132654284 P210032 000
00733132654291 P210032 000
00733132654307 P210032 000
00733132654222 P210032 000
00733132654215 P210032 000
00733132654208 P210032 000
00733132654123 P210032 000
00733132654130 P210032 000
00733132654147 P210032 000
00733132654154 P210032 000
00733132654161 P210032 000
00733132654178 P210032 000
00733132654185 P210032 000
00733132654192 P210032 000
00733132654314 P210032 000
00733132654321 P210032 000
00733132654024 P210032 000
00733132654031 P210032 000
00733132654048 P210032 000
00733132654055 P210032 000
00733132654062 P210032 000
00733132654079 P210032 000
00733132654086 P210032 000
00733132654093 P210032 000
00733132654017 P210032 000
00733132654420 P210032 000
00733132654413 P210032 000
00733132654338 P210032 000
00733132654345 P210032 000
00733132654352 P210032 000
00733132654369 P210032 000
00733132654376 P210032 000
00733132654383 P210032 000
00733132654390 P210032 000
00733132654406 P210032 000
00733132654109 P210032 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.