GORE EXCLUDER AAA ENDOPROSTHESIS

FDA premarket approval P020004/S039 · decided 2009-03-05

Approval details

PMA number

P020004

Supplement

S039

Supplement type

Normal 180 Day Track

Trade name

GORE EXCLUDER AAA ENDOPROSTHESIS

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant

W. L. Gore & Associates, Inc.

Date received

2008-11-03

Decision date

2009-03-05

Days to decision

122 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Phonix, AZ

Statement

APPROVAL FOR THE ADDITION OF THE 31 MM GORE EXCLUDERENDOPROSTHESIS. THE 31 MM GORE EXCLUDERS ENDOPROSTHESIS INCLUDES TWO COMPONENTSTHAT WERE NOT INCLUDED IN PRIOR SUBMISSIONS: THE 31 MM TRUNK-IPSILATERAL LEG AND THE 32MM AORTIC EXTENDER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GOREEXCLUDERS AAA ENDOPROSTHESIS AND IS INTENDED TO EXCLUDE THE ANEURYSM FROM BLOODCIRCULATION IN PATIENTS WHO HAVE APPROPRIATE ANATOMY AS FOLLOWS:1) ADEQUATE ILIAC/FEMORAL ACCESS;2) INFRARENAL AORTI

510(k) clearances by this applicant