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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 NumberS062
Date Received04/24/1996
Decision Date05/20/1996
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 for modifications to the external transmitter coil of the nucleus 22 channel cochlear implant device. The modifications consist of connecting two diodes in parallel with the external transmitter coil to limit esd energy being transmitted to the impalnt by the coil. A change in the manufacturing method for the coil windings will also reduce the effective coil diameter by approximately 0. 1mm.
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