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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.
 
DeviceNUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS)
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
Cochlear Americas
400 inverness parkway,
suite 400
englewood, CO 80112
PMA NumberP840024
Supplement NumberS086
Date Received12/16/2002
Decision Date12/27/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the coil/cable of the esprit 3g speech processor to enable nucleus 22 users to access the technological benefits of the esprit 3g.
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