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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
ApplicantADVANCED BIONICS
28515 WESTINGHOUSE PLACE
VALENCIA, CA 91355
PMA NumberP960058
Supplement NumberS037
Date Received05/10/2004
Decision Date07/23/2004
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR EXPANSION OF THE IN-PROCESS INSPECTION PROCEDURE FOR THE HIRES 90K IMPLANT. NAMELY, THE PMA SUPPLEMENT PROPOSED TO ADD AN ADDITIONAL VISUAL INSPECTION STEP TO ENSURE WELD INTEGRITY BY USING A MINIMUM OF 80X MAGNIFICATION TO VERIFY THE FOLLOWING: 1) COMPLETE CLOSURE OF THE WELD HOLD, 2) ACCEPTABLE WELD QUALITY, AND 3) ABSENCE OF FOREIGN MATERIAL AT THE WELD SITE.
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