Ancure(Tm) Tube System, Ancure(Tm) Bifurcated System
FDA premarket approval P990017 · System, Endovascular Graft, Aortic Aneurysm Treatment
Approval
- Applicant
- Boston Scientific Corp
- Received
- March 15, 1999
- Decision date
- September 28, 1999 (APWD)
- Supplements
- 33, latest August 8, 2003
- Product code
- MIH – System, Endovascular Graft, Aortic Aneurysm Treatment
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.