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ANCURE/AORTOILIAC ENDOGRAFT SYSTEM

FDA premarket approval P990017/S030 · decided 2002-04-24

Approval details

PMA number
P990017
Supplement
S030
Supplement type
Panel Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ANCURE/AORTOILIAC ENDOGRAFT SYSTEM
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Applicant
Boston Scientific Corp
Date received
2001-12-19
Decision date
2002-04-24
Days to decision
126 days
Decision code
APPR
Product code
MIH
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR THE ANCURE AORTOILIAC SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS IN PATIENTS WHOSE ANATOMY DOES NOT ALLOW THE USE OF A TUBE OR BIFURCATED DEVICE.

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510(k) clearances by this applicant

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IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21