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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.
 
Trade NameCOCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namenucleus 24 cochlear implant system (softip)
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS050
Date Received05/21/2009
Decision Date02/02/2010
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the material used in the grey transmitting coil for the freedom sound processor from sabic abs cycolac gpm5500 to sabic medical grade abs cycolac hmg94md.
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