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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 25 Results
productcode MCM PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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PMA
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Mi1260 SONATA 2 Cochlear Implant and Mi1250 SYNCHR... MED-EL CORP. P000025 S114 09/25/2020
MedEl EAS System MED-EL CORP. P000025 S115 10/07/2020
MED-EL Cochlear Implant System MED-EL CORP. P000025 S116 08/25/2020
AudioStream and AudioKey 2.0 MED-EL CORP. P000025 S117 09/25/2020
MED-EL Cochlear Implant System MED-EL CORP. P000025 S118 09/04/2020
MED-EL Cochlear Implant System MED-EL CORP. P000025 S119 10/21/2020
Nucleus 22 Cochlear Implant Systems Cochlear Americas P840024 S092 07/02/2020
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Cochlear Americas P970051 S172 03/17/2020
Nucleus 24 Cochlear Implant Cochlear Americas P970051 S188 04/02/2020
Nucleus CI624 Implant System Cochlear Americas P970051 S191 02/14/2020
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