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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) S-SERIES TM SPEECH PROCESSOR
Generic Namecochlear implant
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS002
Date Received11/25/1997
Decision Date06/22/1998
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for postmarket language study. A postapproval languate study consisting of 20 to 30 children under age 6 will be undertaken using the reynell development language scales revised (rdls). Data will be collected for 3 years at 6-month intervals. The data analysis will include a statistical analysis of effectiveness data -- both the subset of speech intelligibility measures used during the postapproval study as described in amendment#11, dated june 20, 1997, and the reynell test of expressive and receptive ability. Results of the long-term data must be reflected in the labeling, via a pma supplement, when the postapproval study is completed.
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