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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 20 Results
productcode MCM PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
 
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PMA
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MED-EL Cochlear Implant System MED-EL CORP. P000025 S105 09/19/2018
Nucleus 24 Cochlear Implant System Cochlear Americas P970051 S181 09/10/2018
HiRes Ultra 3D Cochlear Implant ADVANCED BIONICS P960058 S129 08/28/2018
HiResolution Bionic Ear System ADVANCED BIONICS P960058 S130 08/13/2018
MED-EL Cochlear Implant System MED-EL CORP. P000025 S102 08/10/2018
MED-EL Cochlear Implant System MED-EL CORP. P000025 S101 07/25/2018
Maestro System Software 7.0 MED-EL CORP. P000025 S097 07/24/2018
Nucleus C1532 Cochlear Implant Cochlear Americas P970051 S180 07/11/2018
Nucleus Cochlear Implant System Cochlear Americas P970051 S173 06/13/2018
Nucleus 24 Cochlear Implant System (Nucleus 7 Soun... Cochlear Americas P970051 S179 05/24/2018
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