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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceVALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP100040
Supplement NumberS008
Date Received04/30/2012
Decision Date10/26/2012
Product Code MIH 
Docket Number 12M-1109
Notice Date 11/08/2012
Advisory Committee Cardiovascular
Clinical TrialsNCT00413231
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF ISOLATED LESIONS (EXCLUDING DISSECTIONS) OF THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING: ILIAC OR FEMORAL ARTERY ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, OR ACCESSORIES; NONANEURYSMAL AORTIC DIAMETER IN THE RANGE OF 18 TO 42 MM (FUSIFORM AND SACCULAR ANEURYSMS/ PENETRATING ULCERS) OR 18 MM TO 44 MM (BLUNT TRAUMATIC AORTIC INJURIES); AND NONANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS >= 20 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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