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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 Nameauditory brainstem implant
PMA NumberP000015
Supplement NumberS005
Date Received08/04/2003
Decision Date08/22/2003
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 the addition of a polyterephthalate (pet) mesh disk. The device, as modified, will be marketed under the trade name nucleus 24 auditory brainstem implant with pet mesh disk and is intended to restore useful hearing in individuals with neurofibromatosis type 2 (nf2) who are 12 years of age or older, via electrical stimulation of the cochlear nucleus.