PMA P940022S023

Device: CLARION CII BIONIC EAR, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055)
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S023
Product code: MCM
Decision date: 2002-09-09
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE COMMERCIAL DISTRIBUTION OF THE CLARION HIFOCUS ELECTRODE WITHOUT THE POSITIONER (MODEL AB-5100-11A) IN ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17-YEARS, 11-MONTHS OF AGE). IT ALSO REQUESTED APPROVAL OF THE HIGH RESOLUTION SPEECH PROCESSING STRATEGY (HIRES SOFTWARE, MODEL NUMBER CI-6055) FOR BOTH PATIENT POPULATIONS.

Current openFDA PMA Record#

Device: CLARION CII BIONIC EAR, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055)
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S023
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2002-09-09
Decision code: APPR
Date received: 2002-07-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE COMMERCIAL DISTRIBUTION OF THE CLARION HIFOCUS ELECTRODE WITHOUT THE POSITIONER (MODEL AB-5100-11A) IN ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17-YEARS, 11-MONTHS OF AGE). IT ALSO REQUESTED APPROVAL OF THE HIGH RESOLUTION SPEECH PROCESSING STRATEGY (HIRES SOFTWARE, MODEL NUMBER CI-6055) FOR BOTH PATIENT POPULATIONS.