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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS CORP.
12740 SAN FERNANDO RD.
SYLMAR, CA 91342
PMA NumberP940022
Date Received06/30/1994
Decision Date03/22/1996
APCB Date 10/18/2002
Product Code MCM 
Docket Number 96M-0490
Notice Date 12/27/1996
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CLARION MULTI-STRATEGY COCHLEAR IMPLANT FOR USE IN AN ADULT POPLUATION
Supplements: S006 S007 S008 S010 S011 S001 S002 S026 S027 S004 S005 S015 
S016  S020 S013 S014 S003 S021 S022 S023 S024 S025 S012 
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