GORE TAG THORACIC ENDOPROSTHESIS

FDA premarket approval P040043/S039 · decided 2011-08-23

Approval details

PMA number

P040043

Supplement

S039

Supplement type

Normal 180 Day 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

2011-03-01

Decision date

2011-08-23

Days to decision

175 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Flagstaff, AZ

Statement

APPROVAL FOR A MODIFIED VERSION OF THE TAG THORACIC ENDOPROSTHESIS. THE TAG DEVICE IS INDICATED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING ADEQUATE ILIAC/ FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM, AND >= 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE ANEURYSM.

510(k) clearances by this applicant