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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 35 Results
productcode MCM PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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PMA
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HiResolution Bionic Ear System ADVANCED BIONICS P960058 S134 01/09/2019
HiResolution Bionic Ear System ADVANCED BIONICS P960058 S135 01/11/2019
Mi1210 SYNCHRONY ST Cochlear Implant MED-EL CORP. P000025 S103 01/22/2019
MED-EL Cochlear Implant System MED-EL CORP. P000025 S107 02/22/2019
HiResolution Bionic Ear System ADVANCED BIONICS P960058 S136 03/08/2019
HiResolution Bionic Ear System ADVANCED BIONICS P960058 S137 03/08/2019
Nucleus 24 Cochlear Implant System Cochlear Americas P970051 S184 03/08/2019
Chorus Sound Processor and SoundWave Professional ... ADVANCED BIONICS P960058 S132 03/12/2019
HiResolution Bionic Ear System ADVANCED BIONICS P960058 S138 03/22/2019
HiResolution Bionic Ear System/AIM System ADVANCED BIONICS P960058 S133 04/12/2019
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