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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.
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.