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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.
 
DeviceTHE TALENT ABDOMINAL STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP070027
Date Received10/18/2007
Decision Date04/15/2008
Withdrawal Date 03/06/2017
Product Code MIH 
Docket Number 08M-0244
Notice Date 04/24/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE TALENT ABDOMINAL STENT GRAFT SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS WITH OR WITHOUT ILIAC INVOLVEMENT HAVING:1) ILIAC/FEMORAL ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES;2) A PROXIMAL AORTIC NECK LENGTH OF >= 10MM; 3) PROXIMAL AORTIC NECK ANGULATION <= 60?; 4) DISTAL ILIAC ARTERY FIXATION LENGTH OF >=15MM;5) AN AORTIC NECK DIAMETER OF 18-32MM AND ILIAC ARTERY DIAMETERS OF 8-22MM; AND 6) VESSEL MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S043 S044 S045 S046 S047 S048 
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