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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.
 
DeviceHIRESOLUTION BIONIC EAR SYSTEM
Generic Nameimplant, cochlear
Applicant
ADVANCED BIONICS
28515 westinghouse place
valencia, CA 91355
PMA NumberP960058
Supplement NumberS033
Date Received02/09/2004
Decision Date02/18/2004
Product Code 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 A NEW AURIA (BEHIND-THE-EAR) ACCESSORY, CALLED THE AURIA T-COIL. THE ACCESSORY PROVIDES AURIA USERS AN OPTIONAL INTERFACE FOR TELEPHONES AND INDUCTION LOOP-BASED ASSISTIVE LISTENING SYSTEM.
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