|
Device | GORE CARDIOFORM 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 | S060 |
Date Received | 07/31/2017 |
Decision Date | 03/30/2018 |
Product Code |
MLV |
Docket Number | 18M-1372 |
Notice Date | 04/17/2018 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00738894
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the GORE CARDIOFORM Septal Occluder. The GORE CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of the following defects of the atrial septum:1) ostium secundum atrial septal defects (ASDs); and2) patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |