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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 Pl.
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
Predetermined Change Control Plan AuthorizedNo
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: S006  S001 S002 S003 S004 S005 S010 S023 S024 S025 S028 
S039 S026 S027 S031 S029 S033 S041 S048 S056 S047 S053 S054 
S059 S070 S063 S071 S066 S067 S060 S061 S036 S034 S032 S035 
S037 S038 S062 S074 S073 S009 S020 S008 S013 S014 S015 S016 
S017 S021 S022 S011 S040 S046 S012 S007 S044 S045 S049 S019 
S051 S055 S052 S058 S057 S050 S072 S064 S068 S069 
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