PMA P960058S010

Device: CLARION DEVICE FITTING SOFTWARE (SCLIN)
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S010
Decision date: 1999-07-16
Approval order statement: Approval for the modifications to the Device Fitting Software for adults and pediatrics. The device, as modified, will be marketed under the trade name Clarion Multi-Strategy Cochlear Implant (Adult) and (Pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve.

Current openFDA PMA Record#

Device: CLARION DEVICE FITTING SOFTWARE (SCLIN)
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S010
Decision date: 1999-07-16
Decision code: APPR
Date received: 1999-03-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the modifications to the Device Fitting Software for adults and pediatrics. The device, as modified, will be marketed under the trade name Clarion Multi-Strategy Cochlear Implant (Adult) and (Pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve.