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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 24 COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namenucleus 24 cochlear implant system (softip)
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS038
Date Received04/21/2006
Decision Date06/14/2006
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) version 1. 3 of the custom sound programming software which includes software modifications and enhancements which will enable recipients of the previous generation nucleus 24 cochlear implants to use the latest approved freedom speech processor, and 2) freedom processor firmware changes related to the processors liquid-crystal display (lcd).
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