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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantADVANCED BIONICS CORP.
PMA NumberP940022
Date Received06/30/1994
Decision Date03/22/1996
Conversion Date 10/18/2002
Product Code
MCM[ Registered Establishments with MCM ]
Docket Number 96M-0490
Notice Date 12/27/1996
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the clarion multi-strategy cochlear implant for use in an adult popluation.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S016 S020 S021 S022 
S023 S024 S025 S026 S027 
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