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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
PMA Number: P140031
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Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 96... 1 08/21/2019 Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630... 1 08/21/2019 Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 963... 1 08/21/2019 Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 96... 1 08/21/2019 Edwards Lifesciences, LLC
Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00... 2 02/14/2019 Edwards Lifesciences, LLC
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm 2 07/13/2018 Edwards Lifesciences, LLC
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 96... 1 01/10/2018 Edwards Lifesciences, LLC
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