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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 NameNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDREN
Classification Nameimplant, cochlear
Generic Namecochlear implant system for children
ApplicantCOCHLEAR AMERICAS
PMA NumberP890027
Date Received05/15/1989
Decision Date06/27/1990
Product Code
MCM[ Registered Establishments with MCM ]
Docket Number 90m-0222
Notice Date 07/27/1990
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 
S047 S048 S049 S050 S051 S052 S053 S054 S055 
S056 S057 
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