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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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MED-EL Cochlear Implant MED-EL CORP. P000025 S100 06/07/2019
Mi1210 SYNCHRONY ST Cochlear Implant MED-EL CORP. P000025 S103 01/22/2019
MED-EL Cochlear Implant System MED-EL CORP. P000025 S104 07/19/2019
+FLEX Active Electrode and Insertion Electrode (IE... MED-EL CORP. P000025 S106 07/02/2019
MED-EL Cochlear Implant System MED-EL CORP. P000025 S107 02/22/2019
FineTuner Echo MED-EL CORP. P000025 S108 05/08/2019
AudioKey 1.0 and AudioLink MED-EL CORP. P000025 S109 05/08/2019
Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant MED-EL CORP. P000025 S110 06/04/2019
MAESTRO System Software 8.0 MED-EL CORP. P000025 S111 09/27/2019
Sonnet 2 (EAS) Audio Processor and Maestro 8.0 Sof... MED-EL CORP. P000025 S112 08/22/2019
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