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. |
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Device | ANCURE(TM) TUBE SYSTEM, ANCURE(TM) BIFURCATED SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P990017 |
Date Received | 03/15/1999 |
Decision Date | 09/28/1999 |
Withdrawal Date
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09/19/2011 |
Product Code |
MIH |
Docket Number | 99M-4280 |
Notice Date | 10/18/1999 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | Yes |
Combination Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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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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