PMA P960058S043

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S043
Product code: MCM
Decision date: 2005-12-23
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR PROCESS CONTROL IMPROVEMENTS TO THE HIRES90K COIL-CASE/ELECTRODE SUBASSEMBLY FINAL MOLDING PROCESS. THE PROPOSED CHANGES INCLUDE AN EXTERNAL THERMOCOUPLE TO PROVIDE CLOSED-LOOP CONTROL OF THE MOLD TEMPERATURE, THEREBY PROVIDING BETTER CONTROL OF THE CURING TEMPERATURE OF THE SILICONE, AND BY CONFIGURING THE MOLD TOOL WITH SPRING WASHER (BELLEVILLE WASHERS) TO ALLOW FOR SMOOTHER MOVEMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR INDIVIDUALS AGED 12 MONTHS AND OLDER WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS TO RESTORE A LEVEL OF AUDITORY SENSATION VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S043
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2005-12-23
Decision code: APPR
Date received: 2005-07-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR PROCESS CONTROL IMPROVEMENTS TO THE HIRES90K COIL-CASE/ELECTRODE SUBASSEMBLY FINAL MOLDING PROCESS. THE PROPOSED CHANGES INCLUDE AN EXTERNAL THERMOCOUPLE TO PROVIDE CLOSED-LOOP CONTROL OF THE MOLD TEMPERATURE, THEREBY PROVIDING BETTER CONTROL OF THE CURING TEMPERATURE OF THE SILICONE, AND BY CONFIGURING THE MOLD TOOL WITH SPRING WASHER (BELLEVILLE WASHERS) TO ALLOW FOR SMOOTHER MOVEMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR INDIVIDUALS AGED 12 MONTHS AND OLDER WITH SEVERE-TO-PROFOUND SENSORINEURAL HEARING LOSS TO RESTORE A LEVEL OF AUDITORY SENSATION VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE.