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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR
ApplicantAdvanced Bionics
28515 Westinghouse Pl.
Valencia, CA 91355
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
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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