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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.
 
Device3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
Cochlear Americas
13059 east peakview avenue
centennial, CO 80111
PMA NumberP830069
Date Received10/14/1983
Decision Date11/26/1984
Withdrawal Date 03/09/2011
Product Code
MCM[ Registered Establishments with MCM ]
Docket Number 84M-0395
Notice Date 12/24/1984
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 
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