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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Cochlear Americas
400 inverness parkway,
suite 400
englewood, CO 80112
PMA NumberP840024
Supplement NumberS088
Date Received10/13/2009
Decision Date11/12/2009
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional labeling to recipients receiving pre-programmed repaired/replaced sound processors.