|
Device | GORE HELEX SEPTAL OCCLUDER |
Generic Name | Transcatheter septal occluder |
Applicant | W.L. GORE & ASSOCIATES,INC 32360 N NORTH VALLEY PARKWAY PHOENIX, AZ 85085-1505 |
PMA Number | P050006 |
Supplement Number | S001 |
Date Received | 09/12/2006 |
Decision Date | 09/21/2007 |
Product Code |
MLV |
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 DESIGN MODIFICATIONS FOR THE CATHETER DELIVERY SYSTEM (HELIX 1.5 DELIVERY SYSTEM). |