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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.
 
DeviceCLARION CII BIONIC EAR SYSTEM (PEDIATRIC)
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
ADVANCED BIONICS
28515 westinghouse place
valencia, CA 91355
PMA NumberP960058
Supplement NumberS027
Date Received10/25/2002
Decision Date11/06/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a revision to the package insert (document number 9196252-001) that modified the percentage of patients who preferred high resolution sound processing to conventional sound processing. This modification is based on updated data received from patients at the 12-month follow-up visit which showed that three of the five patients who originally preferred their conventional strategy at the three-month experimental strategy visit switched their preference to hires. Thus, 48 of 50 patients (96%) ultimately preferred hires.
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