|
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 | S076 |
Date Received | 03/27/2019 |
Decision Date | 04/18/2019 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Remove cytotoxicity and IR inspections for the GORE CARDIOFORM Septal Occluder incoming components. |