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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.

Premarket Approval (PMA) Database

Trade NameHIRESOLUTION BIONIC EAR SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant (pediatric)
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS034
Date Received03/03/2004
Decision Date07/19/2004
Product Code
MCM [ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type normal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Approval Order Statement  Approval for an alternate electrode configuration for the hires90k implant. This alternate electrode is a modified version of the current hifocus electrode, identified as hifocus helix electrode.

Database Updated 02/06/2009

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