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Device | GORE CARDIOFORM Septal Occluder and 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 | S091 |
Date Received | 02/19/2021 |
Decision Date | 08/02/2021 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of a new ethylene oxide sterilization cycle to be performed at a new sterilization site (Sterigenics US, LLC located at 2400 Airport Road, Santa Teresa, NM) |