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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 NameCLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE
Classification Nameimplant, cochlear
Generic Namecochlear implant (pediatric)
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS028
Date Received11/01/2002
Decision Date11/25/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor changes to the hifocus electrode to better facilitate the packing of the cochleostomy and electrode insertion. Specifically, the changes are to move the offset region approximately 3 mm further away from the current location.
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