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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 MULTICHANNEL IMPLANTABLE HEARING PROSTHESI
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantCOCHLEAR AMERICAS
PMA NumberP840024
Date Received05/31/1984
Decision Date10/31/1985
Product Code
MCM[ Registered Establishments with MCM ]
Docket Number 85M-0524
Notice Date 12/09/1985
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S017 S018 S019 S020 
S021 S022 S023 S024 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 S055 S056 S057 
S058 S059 S060 S061 S062 S063 S064 S065 S066 
S067 S068 S069 S070 S071 S072 S073 S074 S075 
S076 S077 S078 S079 S080 S081 S082 S083 S084 
S085 S086 S087 S088 
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