PMA P960058S058

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S058
Product code: MCM
Decision date: 2007-07-02
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THREE ?VACUUM BAKE AIR FLOW ENHANCEMENTS? TO THE HIRES90K COCHLEAR IMPLANT, AS FOLLOWS: 1) THE BOTTOM COVER SHIELD INSIDE THE HIRES90K CASE WAS MODIFIED FROM HAVING A ?V?-SHAPED CHANNEL TO HAVING A LARGER ?U?-SHAPED CHANNEL. 2) HOLES WERE ADDED TO THE INSULATING KAPTON DISC. 3) SLOTS WERE IMPLEMENTED INSIDE THE FEEDTHROUGH CASE. 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: S058
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2007-07-02
Decision code: APPR
Date received: 2007-05-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THREE ?VACUUM BAKE AIR FLOW ENHANCEMENTS? TO THE HIRES90K COCHLEAR IMPLANT, AS FOLLOWS: 1) THE BOTTOM COVER SHIELD INSIDE THE HIRES90K CASE WAS MODIFIED FROM HAVING A ?V?-SHAPED CHANNEL TO HAVING A LARGER ?U?-SHAPED CHANNEL. 2) HOLES WERE ADDED TO THE INSULATING KAPTON DISC. 3) SLOTS WERE IMPLEMENTED INSIDE THE FEEDTHROUGH CASE. 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.