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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.
 
DeviceCLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) HIFOCUS ELECTRODE
Generic NameImplant, cochlear
ApplicantAdvanced Bionics Corp.
12740 San Fernando Rd.
Sylmar, CA 91342
PMA NumberP940022
Supplement NumberS014
Date Received03/22/2000
Decision Date07/13/2000
APCB Date10/18/2002
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT HIFOCUS ELECTRODE FOR POST-LINGUAL SEVERE TO PROFOUND HEARING LOSS WHERE LIMITED BENEFIT HAS BEEN OBTAINED WITH THE USE OF HEARING AIDS.
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