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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 CAPTIVIA DELIVERY SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP100040
Supplement NumberS012
Date Received07/29/2013
Decision Date01/22/2014
Product Code MIH 
Docket Number 14M-167
Notice Date 02/04/2014
Advisory Committee Cardiovascular
Clinical TrialsNCT01114724
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 CAPTIVIA DELIVERY SYSTEM (VALIANT CAPTIVIA). THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF ALL LESIONS OF THE DESCENDING THORACIC AORTA (DTA) IN PATIENTS HAVING THE APPROPRIATE ANATOMY INCLUDING: 1) 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 MM TO 42 MM (FUSIFORM AND SACCULAR ANEURYSMS/PENETRATING ULCERS), OR 18 MM TO 44 MM (BLUNT TRAUMATIC AORTIC INJURIES), OR 20 MM TO 44 MM (DISSECTIONS); AND NONANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS ¿ 20 (FUSIFORM AND SACCULAR ANEURYSMS/ PENETRATING ULCERS), LANDING ZONE ¿20 MM PROXIMAL TO THE PRIMARY ENTRY TEAR (BLUNT TRAUMATIC AORTIC INJURIES, DISSECTIONS). THE PROXIMAL EXTENT OF THE LANDING ZONE MUST NOT BE DISSECTED.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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