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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 MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE
Classification Nameimplant, cochlear
Generic Namecochlear implant (pediatric)
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS014
Date Received06/22/2000
Decision Date11/15/2000
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 clarion(r) multi-strategy cochlear implant hifocus electrode for pediatric use. The device, as modified, will be marketed under the trade name clarion(r) multi-strategy cochlear implant (pediatric) hifocus electrode and is indicated for severely and profoundly hearing impaired children ages 18-months to 17-years.
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