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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 FIREFLY (ADULT)
Generic NameImplant, cochlear
ApplicantAdvanced Bionics Corp.
12740 San Fernando Rd.
Sylmar, CA 91342
PMA NumberP940022
Supplement NumberS024
Date Received09/16/2002
Decision Date09/23/2002
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 FIREFLY, MODEL CI-5705. THIS DEVICE PROVIDES SYSTEM VERIFICATION CAPABILITY TO CLINICIANS AND PARENTS INCLUDING BATTERY CHARGE STATUS, SYSTEM LOCK STATUS, AND PROGRAM SLOT INFORMATION.
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