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Device | GORE® CARDIOFORM Septal Occluder, 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 | S098 |
Date Received | 01/20/2022 |
Decision Date | 02/22/2022 |
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 Removal of cytotoxicity and infrared spectroscopy inspections for incoming components. |