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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 35 Results
productcode MCM PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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Device
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PMA
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Sort by PMA Number [0-9]
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MED-EL Cochlear Implant System MED-EL CORP. P000025 S104 07/19/2019
Sonnet 2 (EAS) Audio Processor and Maestro 8.0 Sof... MED-EL CORP. P000025 S112 08/22/2019
HiResolution Bionic Ear System ADVANCED BIONICS P960058 S141 08/23/2019
HiResolution Bionic Ear System ADVANCED BIONICS P960058 S142 08/27/2019
Nucleus 24 Cochlear Implant System Cochlear Americas P970051 S189 08/27/2019
HiResolution Bionic Ear System ADVANCED BIONICS P960058 S131 08/30/2019
MAESTRO System Software 8.0 MED-EL CORP. P000025 S111 09/27/2019
Nucleus 24 Cochlear Implant System (EA22 Stiffener... Cochlear Americas P970051 S192 10/08/2019
COMBI 40+ Cochlear Implant System MED-EL CORP. P000025 S113 10/15/2019
HiResolution Bionic Ear System ADVANCED BIONICS P960058 S143 10/25/2019
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