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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 NumberS054
Date Received07/17/2006
Decision Date07/28/2006
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a cochlear implant system name change from "hiresolution bionic ear system" to "harmony hiresolution bionic ear system". The device, as modified, will be marketed under the trade name harmony hiresolution bionic ear system and is indicated for adults and the pediatric population aged 12 months through 17 years, 11 months of age.
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