EXCLUDER BIFURCATED ENDOPROSTHESIS

FDA premarket approval P020004 · decided 2002-11-06

Approval details

PMA number

P020004

Trade name

EXCLUDER BIFURCATED ENDOPROSTHESIS

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant

W. L. Gore & Associates, Inc.

Date received

2002-01-23

Decision date

2002-11-06

Days to decision

287 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Phonix, AZ

Statement

APPROVAL FOR THE EXCLUDER BIFURCATED ENDOPROSTHESIS. THE EXCLUDER BIFURCATED ENDOPROSTHESIS IS INTENDED TO EXCLUDE THE ANEURYSM FROM THE BLOOD CIRCULATION IN PATIENTS DIAGNOSED WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS (AAA) DISEASE AND WHO HAVE APPROPRIATE ANATOMY AS DESCRIBED: 1) ADEQUATE ILIAC/FEMORAL ACCESS 2) INFRARENAL AORTIC NECK TREATMENT DIAMETER RANGE OF 19-26 MM AND A MINIMUM AORTIC NECK LENGTH OF 15 MM 3) PROXIMAL AORTIC NECK ANGULATION <= 60 DEGREES 4) ILIAC ARTERY TREATMENT DIAMET

510(k) clearances by this applicant