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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSONNET 2, SONNET 2 EAS, RONDO 3, MAESTRO 8, and MAESTRO 9
Generic Nameimplant, cochlear
ApplicantMED-EL CORP.
furstenweg 77a
innsbruck 6020
PMA NumberP000025
Supplement NumberS120
Date Received09/28/2020
Decision Date06/25/2021
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for Front-End Signal Processing Features: Ambient Noise Reduction, Transient Noise Reduction and Adaptive Intelligence.
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