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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 NameHIRESOLUTION BIONIC EAR SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant (pediatric)
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS032
Date Received12/09/2003
Decision Date12/16/2003
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 an optional accessory item that can be used with the platinum headpiece and auria headpiece. This item, named headpiece spacer, is a passive piece of elastomer intended to be placed between the headpiece inner surface and the patient's scalp. The device, as modified, will be marketed under the trade name hiresolution bionic ear system and is indicated for adults with post-lingual onset of severe-to-profound hearing loss and in children with profound hearing loss (12-months to 17 years, 11-months of age).
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