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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.
 
DeviceVALIANT THORACIC STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP100040
Date Received10/08/2010
Decision Date04/01/2011
Product Code MIH 
Docket Number 11M-0257
Notice Date 04/20/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00413231
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE FALIANT THORACIC STENT GRAFT WITH THE CAPTIVA DELIVERY SYSTEM. THE DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF FUSIFORM AND ANEURYSMS/PENETRATING ULCERS OF THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING: 1) ILIAC/FEMORAL ACCESS VESSLE MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES; 2) NON-ANEURYSMAL AORTIC DIAMETER IN THE RANGE OF 18-42 MM; AND 3) NON-ANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS >=20 MM.
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 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S044 S045 S046 S047 S048 S049 S050 S051 
S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 
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