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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 NumberS061
Date Received03/24/2008
Decision Date04/21/2008
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an updated change to the instructions for use (ifu) for the iconnect, as accessory to the advanced bionics behind-the-ear speech processors, as follows: from: ?the auria iconnect can only use a standard size 10 battery. Do not use any other battery. ? to: ?only zenipower size 10a batteries from advanced bionics are certified for use with the iconnect. Please contact advanced bionics of its authorized distributors to purchase these batteries. Other batteries may not provide sufficient battery life when used with the iconnect. ?.
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