GORE TAG THORACIC ENDOPROSTHESIS

FDA premarket approval P040043/S031 · decided 2010-03-23

Approval details

PMA number

P040043

Supplement

S031

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

2009-09-24

Decision date

2010-03-23

Days to decision

180 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Flagstaff, AZ

Statement

APPROVAL FOR ADDING THE 45MM TAG THORACIC ENDOPROSTHESIS TO THE ALREADY EXISTING TAG THORACIC ENDOPROSTHESIS PRODUCT FAMILY. 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 23-42MM, AND >=2CM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE ANEURYSM.

510(k) clearances by this applicant