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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 CHANNEL COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
Cochlear Americas
13059 e peakview ave
centennial, CO 80111
PMA NumberP890027
Supplement NumberS038
Date Received04/24/1997
Decision Date06/11/1997
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL TO IMPLEMENT A DESIGN CHANGE TO THE TWO-PIN SOCKET ON THE HEADSET MICROPHONE. THE TRANSMITTING COIL IS CONNECTED TO THE MICROPHONE VIA A CABLE WHICH IS PLUGGED INTO THIS TWO-PIN SOCKET. THIS CHANGE WOULD ALSO ENTAIL MAKING A SLIGHT MODIFICATION OT THE DESIGN OF THE SHELL OF THE HEADSET MICROPHONE IN ORDER TO ACCOMMODATE THE NEW DESIGN OF THE TWO-PIN SOCKET.
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