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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 NameCLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE
Generic Namecochlear implant
ApplicantADVANCED BIONICS CORP.
PMA NumberP960058
Supplement NumberS004
Date Received03/30/1998
Decision Date05/28/1998
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modified clarion device in which the implantable cochlear stimulator (ics) housing is made of zirconia instead of alumina. The new housing configuration is to be referred to as the cim 3.
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