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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.
Generic Namecochlear implant (pediatric)
PMA NumberP960058
Supplement NumberS010
Date Received03/24/1999
Decision Date07/16/1999
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modifications to the device fitting software for adults and pediatrics. The device, as modified, will be marketed under the trade name clarion multi-strategy cochlear implant (adult) and (pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve.