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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplant, cochlear
Generic Namecochlear implant
PMA NumberP960058
Supplement NumberS114
Date Received01/02/2015
Decision Date08/14/2015
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanding the naída ci sound processor family, which are external components of the hiresolution bionic ear system, by adding two new sound processors (ci q90 and ci q30), new versions of the powercel battery, and a new version of the soundwave professional suite fitting software.