PMA P960058S024

Device: BTE FIREFLY (PEDIATRIC)
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S024
Product code: MCM
Decision date: 2002-09-23
Classification: Implant, Cochlear
Generic name: Implant, cochlear
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.

Current openFDA PMA Record#

Device: BTE FIREFLY (PEDIATRIC)
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S024
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2002-09-23
Decision code: APPR
Date received: 2002-09-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.