|
Device | GORE CARDIOFORM ASD 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 | S083 |
Date Received | 06/02/2020 |
Decision Date | 07/02/2020 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to the device Instructions For Use to add a warning related to risks associated with physician modification of the device before use. |