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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 & CLARION CII BIONIC EAR SYSTEMS
Classification Nameimplant, cochlear
Generic Namecochlear implant (pediatric)
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS035
Date Received04/15/2004
Decision Date05/14/2004
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Expansion of sterilization capacity using an alternate sterilization chamber.
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