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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
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
ADVANCED BIONICS
28515 westinghouse place
valencia, CA 91355
PMA NumberP960058
Supplement NumberS020
Date Received04/12/2002
Decision Date04/23/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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