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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.
 
DeviceBTE(BEHIND-THE-EAR)T-MIC
Generic NameImplant, cochlear
ApplicantAdvanced Bionics Corp.
12740 San Fernando Rd.
Sylmar, CA 91342
PMA NumberP940022
Supplement NumberS020
Date Received04/12/2002
Decision Date04/23/2002
APCB Date10/18/2002
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE BTE T-MIC, AND IN-THE-EAR MICROPHONE ACCESSORY ITEM TO BE OFFERED FOR USE WITH THE BTE SOUND PROCESSOR, AND APPROVAL OF THE HIFOCUS I SURGICAL INSTRUCTION VIDEO, WHICH WILL BE DISTRIBUTED AS PART OF THE SURGEON'S KIT.
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