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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(TM) MULTI-STRATEGY COCHLEAR IMPLANT
Classification Nameimplant, cochlear
Generic Namecochlear implant (adult)
ApplicantADVANCED BIONICS CORP.
PMA NumberP940022
Supplement NumberS025
Date Received09/19/2002
Decision Date09/23/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the product name of the hires software, model number ci-6055. The software will be marketed under the trade name soundwave professional suite, model number ci-6055, and is indicated for use 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).
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