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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Generic Nameimplant, cochlear
12740 san fernando rd.
sylmar, CA 91342
PMA NumberP940022
Supplement NumberS011
Date Received03/24/1999
Decision Date07/16/1999
APCB Date 10/18/2002
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the modifications to the Device Fitting Software for adults and pediatrics. The device, as modified, will be marketed under the trade name Clarion Multi-Strategy Cochlear Implant (Adult) and (Pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve.