PMA P960058S079

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S079
Product code: MCM
Decision date: 2009-03-18
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE HIRES 90K MOCK-UP AS STERILE INSTEAD OF NON-STERILE, AND TO ESTABLISH THE SHELF LIFE AT THREE YEARS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HARMONY HIRESOLUTION BIONIC EAR SYSTEM HIRES 90K MOCK-UP (MOCK-UP) AND IS INDICATED FOR INDIVIDUALS AGED TWELVE MONTHS AND OLDER WITH SEVERE-TO PROFOUND SENSORINEURAL HEARING LOSS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.

Current openFDA PMA Record#

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S079
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2009-03-18
Decision code: APPR
Date received: 2009-02-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE HIRES 90K MOCK-UP AS STERILE INSTEAD OF NON-STERILE, AND TO ESTABLISH THE SHELF LIFE AT THREE YEARS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HARMONY HIRESOLUTION BIONIC EAR SYSTEM HIRES 90K MOCK-UP (MOCK-UP) AND IS INDICATED FOR INDIVIDUALS AGED TWELVE MONTHS AND OLDER WITH SEVERE-TO PROFOUND SENSORINEURAL HEARING LOSS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.