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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameGORE TAG THORACIC ENDOPROSTHESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft
ApplicantW. L. GORE & ASSOCIATES, INC.
PMA NumberP040043
Date Received10/04/2004
Decision Date03/23/2005
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 05M-0320
Notice Date 08/12/2005
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the tag thoracic endoprosthesis and delivery catheter. The device is intended for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy including: 1) adequate iliac/femoral access. 2) aortic inner diameter in the range of 23-37 mm. 3) >=2 cm non-aneurysmal aorta proximal and distal to the aneurysm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 
S025 S026 S027 S029 S030 S031 
S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 
S045 S046 S047 S048 S049 S050 
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