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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 Name3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantCOCHLEAR AMERICAS
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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