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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.
 
Trade NameNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantCOCHLEAR CORP.
PMA NumberP840024
Supplement NumberS060
Date Received11/24/1995
Decision Date03/26/1996
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to make the following changes to the spectra 22 speech processor:1)the printed circuit board will be redesigned from a multi-layer board configuration to a single-layer board configuration. 2)an audio mixing function, called the autoswitching audio circuit, will be included. 3) the clock oscillator frequency will be changed from a nominal 5 mhz to 5. 011 mhz. 4)components will be added to give further protection from electrostatic discharge (esd). 5)the ear-level microphone power supply will be changed to a costant current source. 6)the external input socket will be replaced with amore robust type. 7)the patient switch positions will be changed to put the "normal" sensitivity selection first. 8)a longer-life battery will be provided. 9)a resistor will be inserted in series to protect the back-up battery from excessive current. 10)there will be a version of the spectra 22 speech processor which provides increased transmitter power. 11)some manufacturing test parameters will be slightly modified. 12)four tests will be added during the manufacturing process. 13)the user instruction manual will be revised.
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