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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 CII BIONIC EAR SYSTEM (ADULT)
Generic NameImplant, cochlear
ApplicantAdvanced Bionics Corp.
12740 San Fernando Rd.
Sylmar, CA 91342
PMA NumberP940022
Supplement NumberS026
Date Received10/25/2002
Decision Date11/01/2002
APCB Date10/18/2002
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES TO THE POSTMARKET STUDY PROTOCOL: 1) USE OF ONLY THE PB-K TEST TO DETERMINE CANDIDACY IN CHILDREN 4 YEARS THROUGH 17 YEARS OF AGE AT TIME OF IMPLANT. 2) SUBSTITUTION OF THE PB-K TEST FOR THE ESP TEST AS AN OUTCOME MEASURE. 3) DIVISION OF THE YOUNGEST AGE GROUP INTO TWO GROUPS. 4) ADDITIONAL INCLUSION/EXCLUSION CRITERIA FOR ADULTS AND CHILDREN.
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