|
Device | EXCLUDER BIFURCATED ENDOPROTHESIS |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | W.L. GORE & ASSOCIATES,INC 32360 N. North Valley Parkway Phoenix, AZ 85085 |
PMA Number | P020004 |
Supplement Number | S006 |
Date Received | 05/10/2004 |
Decision Date | 06/02/2004 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LOW PERMEABILITY VERSION OF THE GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. |
Post-Approval Study | Show Report Schedule and Study Progress |