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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 6 of 6 Results
productcode MVK PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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Device
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PMA
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Decision
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ASSURE Wearable Cardioverter Defibrillator (WCD) S... Kestra Medical Technologies, I P200037 S005 10/27/2022
Assure Wearable Cardioverter Defibrillator (WCD) s... Kestra Medical Technologies, I P200037 S004 10/25/2022
LifeVest® Wearable Defibrillator ZOLL MANUFACTURING CORPORATION P010030 S160 08/18/2022
LifeVest Wearable Defibrillator ZOLL MANUFACTURING CORPORATION P010030 S159 06/01/2022
LifeVest® Wearable Defibrillator ZOLL MANUFACTURING CORPORATION P010030 S155 01/26/2022
LifeVest® Wearable Defibrillator ZOLL MANUFACTURING CORPORATION P010030 S157 01/25/2022
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