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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
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS053
Date Received03/08/2006
Decision Date03/22/2006
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the electrostatic discharge (esd) precaution in the hiresolution bionic ear system package insert.
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