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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 20 Results
productcode MCM PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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Neuro Cochlear Implant System Oticon Medical P200021 S001 08/20/2021
SONNET 2, SONNET 2 EAS, RONDO 3, MAESTRO 8, and MA... MED-EL CORP. P000025 S120 06/25/2021
Neuro Cochlear Implant System Oticon Medical P200021 06/23/2021
Nucleus 22 Cochlear Implant System Cochlear Americas P840024 S091 06/09/2021
Nucleus 22 Cochlear Implant System Cochlear Americas P890027 S060 06/09/2021
Nucleus 24 Cochlear Implant System Cochlear Americas P970051 S190 06/09/2021
HiResolution Bionic Ear System ADVANCED BIONICS P960058 S153 04/29/2021
HiResolution Bionic Ear System ADVANCED BIONICS P960058 S152 04/23/2021
Nucleus Cochlear Implant System Cochlear Americas P970051 S203 04/21/2021
Nucleus 24 Cochlear Implant System Cochlear Americas P970051 S204 03/26/2021
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