GORE EXCLUDER AAA ENDOPROSTHESIS

FDA premarket approval P020004/S075 · decided 2012-11-20

Approval details

PMA number

P020004

Supplement

S075

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GORE EXCLUDER AAA ENDOPROSTHESIS

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant

W. L. Gore & Associates, Inc.

Date received

2012-10-04

Decision date

2012-11-20

Days to decision

47 days

Decision code

APPR

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Phonix, AZ

Statement

APPROVAL FOR THE MODIFICATION OF THE DELIVERY SYSTEM FOR THE FOLLOWING DEVICE COMPONENTS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS ON THE SIM-PULL (ORIGINAL) AND C3 (EMDS) CATHETERS IN ORDER TO LOWER THEIR DELIVERY PROFILES AS OUTLINED BELOW: 1) 16, 18 AND 20 MM CONTRALATERAL LEGS FROM 18 FR TO 12 FR; 2) 23 MM CONTRALATERAL LEG FROM 18 FR TO 14 FR; 3) 27 MM COLATERAL LEG FROM 18 FR TO 15 FR; 4) 23, 26, 28.5 MM AORTIC EXTENDERS FROM 18 FR TO 16 FR; 5) 32 MM AORTIC EXTENDER FROM 20 FR TO 17 FR; 6) 3

510(k) clearances by this applicant