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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.
 
DeviceCPI SWITCH BOX
Generic NameImplant, cochlear
ApplicantAdvanced Bionics Corp.
12740 San Fernando Rd.
Sylmar, CA 91342
PMA NumberP940022
Supplement NumberS022
Date Received05/28/2002
Decision Date06/06/2002
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 CPI SWITCH BOX (FORMERLY A/B SWITCH BOX). THE CPI SWITCH BOX IS AN INTERFACE BOX TO FACILITATE THE CONNECTION OF TWO PROGRAMMING CABLES TO THE EXISTING CPI (CLINICIAN'S PROGRAMMING INTERFACE).
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