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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.
28515 westinghouse place
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 report
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.