GORE EXCLUDER AAA ENDOPROSTHESIS

FDA premarket approval P020004/S023 · decided 2007-06-26

Approval details

PMA number

P020004

Supplement

S023

Supplement type

Special (Immediate Track)

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

GORE EXCLUDER AAA ENDOPROSTHESIS

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant

W. L. Gore & Associates, Inc.

Date received

2007-05-21

Decision date

2007-06-26

Days to decision

36 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Phonix, AZ

Statement

APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO EMPHASIZE THE APPROPRIATE WITHDRAWAL PROCEDURES FOR THE DELIVERY CATHETER AND SHEATH IF RESISTANCE IS FELT DURING REMOVAL. THESE CHANGES INCLUDED MODIFICATIONS TO THE DIRECTIONS FOR USE AS WELL AS THE ADDITION OF A WARNING/ PRECAUTION REGARDING THE POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH FORCIBLY WITHDRAWING THE DELIVERY CATHETER THROUGH THE INTRODUCER SHEATH.

510(k) clearances by this applicant