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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.
 
DeviceTALENT ABDOMINAL STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP070027
Supplement NumberS011
Date Received08/10/2009
Decision Date02/04/2010
Withdrawal Date03/06/2017
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING THE TALENT CONVERTER STENT GRAFT AND TALENT OCCLUDER ASLINE EXTENSIONS TO THE ALREADY EXISTING TALENT ABDOMINAL PRODUCT FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TALENT CONVERTER STENT GRAFT SYSTEM WITHXCELERANT HYDRO DELIVERY SYSTEM & TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM. THE TALENT CONVERTER IS INDICATED FOR SECONDARY ENDOVASCULAR INTERVENTION IN PATIENTS HAVING RECEIVED PRIOR ENDOVASCULAR REPAIR OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS USING THE TALENTOR ANEURX BIFURCATED STENT GRAFTS IN WHICH THERE IS INADEQUATE PROXIMAL FIXATION, SEAL, OVERLAPPING OF MODULAR COMPONENTS OR UNATTAINABLE CONTRALATERAL LIMB CANNULATION. THE TALENT OCCLUDER IS INDICATED FOR ENDOLUMINAL OCCLUSION OF THE COMMON ILIAC ARTERY IN ORDER TO PREVENTRETROGRADE BLOOD INTO THE ANEURYSM SAC WHEN USED IN CONJUNCTION TO A FEM-FEM BYPASS.
Post-Approval StudyShow Report Schedule and Study Progress
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