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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 NameMULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
Generic Nameelectrode positioner
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS008
Date Received10/27/1998
Decision Date01/19/1999
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expansion of the indication for use of the advanced bionics clarion multi-strategy cochlear implant to include children 18 months and older.
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