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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 NameCI24R(ST) COCHLEAR IMPLANT
Classification Nameimplant, cochlear
Generic Namenucleus 24 cochlear implant system
ApplicantCOCHLEAR CORP.
PMA NumberP970051
Supplement NumberS010
Date Received02/23/2000
Decision Date08/21/2000
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design modification including the straight electrode of the ci 24 m with the 24 k downsized stimulator receiver. The device, as modified, will be marketed under the trade name ci 24r(st), and is indicated for children age 18 months through 17 years of age who have bilateral profound sensorineural deafness and demonstrate little or no benefit from appropriate binaural hearing aids, and for adults, age 18 years and older who have bilateral moderate to profound sensorineural hearing loss and obtain limited benefit from appropriate hearing aids.
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