|
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 | S014 |
Date Received | 09/17/2009 |
Decision Date | 01/05/2011 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00581308
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATED DEVICE LABELING. |