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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 NameINTRODUCTION CP900 SERIES RECHARGEABLE BATTERIES (A29 AND A30)
Classification Nameimplant, cochlear
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS112
Date Received09/26/2013
Decision Date12/20/2013
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for introduction of the rechargeable batteries (a29 and a30) intended for use with the cp900 series of sound processor (cp910 and cp920).
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