GORE TAG THORACIC ENDOPROSTHESIS

FDA premarket approval P040043/S051 · decided 2013-09-10

Approval details

PMA number

P040043

Supplement

S051

Supplement type

Panel Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GORE TAG THORACIC ENDOPROSTHESIS

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant

W. L. Gore & Associates, Inc.

Date received

2013-03-14

Decision date

2013-09-10

Days to decision

180 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Flagstaff, AZ

Statement

APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS. THIS DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ALL LESIONS OF THE DESCENDING THORACIC AORTA, INCLUDING:1) ISOLATED LESIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM; AND C) > 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION.2) TYPE B DISSECTIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) >

510(k) clearances by this applicant