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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 NameHARMONY HIRESOLUTION BIONIC EAR SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS079
Date Received02/23/2009
Decision Date03/18/2009
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the hires 90k mock-up as sterile instead of non-sterile, and to establish the shelf life at three years. The device, as modified, will be marketed under the trade name harmony hiresolution bionic ear system hires 90k mock-up (mock-up) and is indicated for individuals aged twelve months and older with severe-to profound sensorineural hearing loss via electrical stimulation of the auditory nerve.
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