PMA P960058S054

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S054
Product code: MCM
Decision date: 2006-07-28
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A COCHLEAR IMPLANT SYSTEM NAME CHANGE FROM "HIRESOLUTION BIONIC EAR SYSTEM" TO "HARMONY HIRESOLUTION BIONIC EAR SYSTEM". THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HARMONY HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS AND THE PEDIATRIC POPULATION AGED 12 MONTHS THROUGH 17 YEARS, 11 MONTHS OF AGE.

Current openFDA PMA Record#

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S054
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2006-07-28
Decision code: APPR
Date received: 2006-07-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A COCHLEAR IMPLANT SYSTEM NAME CHANGE FROM "HIRESOLUTION BIONIC EAR SYSTEM" TO "HARMONY HIRESOLUTION BIONIC EAR SYSTEM". THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HARMONY HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS AND THE PEDIATRIC POPULATION AGED 12 MONTHS THROUGH 17 YEARS, 11 MONTHS OF AGE.