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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.
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP840024
Date Received05/31/1984
Decision Date10/31/1985
Product Code MCM 
Docket Number 85M-0524
Notice Date 12/09/1985
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination ProductNo
Supplements: S058 S059 S060 S061 S062 S063 S064 S065 S066 S067  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 S068 S069 S073 S074 S075 S081 S080 
S083 S087 S079 S078 S089 S076 S077 S070 S071 S072 S084 S085 
S086 S082 S088 S090 S094 S093 S091 S092