GORE TAG THORACIC ENDOPROSTHESIS

FDA premarket approval P040043/S040 · decided 2012-01-13

Approval details

PMA number

P040043

Supplement

S040

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

GORE TAG THORACIC ENDOPROSTHESIS

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant

W. L. Gore & Associates, Inc.

Date received

2011-07-01

Decision date

2012-01-13

Days to decision

196 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Flagstaff, AZ

Statement

APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS. THE DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ISOLATED LESIONS (NOT INCLUDING DISSECTIONS) 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 LESION.

510(k) clearances by this applicant