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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.
 
DeviceMULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)
ApplicantAdvanced Bionics
28515 Westinghouse Pl.
Valencia, CA 91355
PMA NumberP960058
Supplement NumberS008
Date Received10/27/1998
Decision Date01/19/1999
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for expansion of the indication for use of the Advanced Bionics CLARION Multi-Strategy Cochlear Implant to include children 18 months and older.
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