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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.
Classification Nameimplant, cochlear
Generic Namenucleus 24 cochlear implant system
PMA NumberP970051
Supplement NumberS019
Date Received10/23/2001
Decision Date03/21/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the sp-10 behind-the-ear speech processor with ace, cis and speak speech coding strategies. The device, as modified, will be marketed under the trade name esprit3g and is intended to be used with the ci24m, ci24r(st) and ci24r(cs) cochlear implants.