PMA P960058S034

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S034
Product code: MCM
Decision date: 2004-07-19
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR AN ALTERNATE ELECTRODE CONFIGURATION FOR THE HIRES90K IMPLANT. THIS ALTERNATE ELECTRODE IS A MODIFIED VERSION OF THE CURRENT HIFOCUS ELECTRODE, IDENTIFIED AS HIFOCUS HELIX ELECTRODE.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S034
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2004-07-19
Decision code: APPR
Date received: 2004-03-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN ALTERNATE ELECTRODE CONFIGURATION FOR THE HIRES90K IMPLANT. THIS ALTERNATE ELECTRODE IS A MODIFIED VERSION OF THE CURRENT HIFOCUS ELECTRODE, IDENTIFIED AS HIFOCUS HELIX ELECTRODE.