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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, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055)
Classification Nameimplant, cochlear
Generic Namecochlear implant (adult)
ApplicantADVANCED BIONICS CORP.
PMA NumberP940022
Supplement NumberS023
Date Received07/29/2002
Decision Date09/09/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the commercial distribution of the clarion hifocus electrode without the positioner (model ab-5100-11a) in adults with post-lingual onset of severe-to-profound hearing loss and in children with profound hearing loss (12-months to 17-years, 11-months of age). It also requested approval of the high resolution speech processing strategy (hires software, model number ci-6055) for both patient populations.
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