Medical Device Recalls
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PMA Number: P140031/S074 |
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Product Description
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Recall
Class
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FDA Recall
Posting Date
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Recalling Firm
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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) (29mm) 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 |
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