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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameANCURE(TM) TUBE SYSTEM, ANCURE(TM) BIFURCATED SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular tube & bifurcated graft systems
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP990017
Date Received03/15/1999
Decision Date09/28/1999
Withdrawal Date 09/19/2011
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 99M-4280
Notice Date 10/18/1999
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the ancure tube and bifurcated systems and the ancure iliac balloon catheter (9 mm to 14 mm sizes). This device has the following indications for use: the ancure(tm) tube system is indicated for the endovascular treatment of infrarenal abdominal aortic aneurysms (aaa) in patients having adequate iliac/femoral access, infrarenal non-aneurysmal neck length of at least 15 mm and a diameter of no greater than 26mm, distal segment neck length of 12mm and diameter of no greater than 26mm, and morphology suitable for endovascular repair. The ancure(tm) bifurcated system is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients having adequate iliac/femoral access, infrarenaln non-aneurysmal neck length of at least 15mm and a diameter of no greater than 26mm, distal segment lengths of at least 20mm and diameters no greater than 13. 4mm, and morphology suitable for endovascular repair. The ancure(tm) iliac balloon catheter is indicated for use in securing the attachment systems in the iliac arteries and/or to expand vascular prosthesis limbs of the ancure(tm) endograft(r) vascular prosthesis.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 S013 S015 S016 S017 S020 S021 S022 
S023 S024 S025 S026 S027 S028 S029 S030 S031 
S032 S034 S035 S036 S037 S038 
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