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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 NameNUCLEUS COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS091
Date Received07/16/2012
Decision Date05/28/2013
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the aqua accessory for the nucleus cochlear implant system. The aqua accessory is a water resistant pouch that is sealable at one end, and holds the external nucleus 5 cp810 sound processor and coil. It may be used for up to an hour to keep the external components dry during use in water (e. G. , swimming). The aqua accessory is intended for unilateral or bilateral use by cochlear implant recipients who have the ability to notify a caregiver or the ability to remove the device on their own, if the device becomes hot or if there is a change in sound quality.
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