PMA P960058S014

Device: CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S014
Product code: MCM
Decision date: 2000-11-15
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT HIFOCUS ELECTRODE FOR PEDIATRIC USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE AND IS INDICATED FOR SEVERELY AND PROFOUNDLY HEARING IMPAIRED CHILDREN AGES 18-MONTHS TO 17-YEARS.

Current openFDA PMA Record#

Device: CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S014
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2000-11-15
Decision code: APPR
Date received: 2000-06-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT HIFOCUS ELECTRODE FOR PEDIATRIC USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE AND IS INDICATED FOR SEVERELY AND PROFOUNDLY HEARING IMPAIRED CHILDREN AGES 18-MONTHS TO 17-YEARS.