PMA P960058S109

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S109
Product code: MCM
Decision date: 2015-04-14
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A LABELING/PACKAGING CHANGE TO THE HIRES 90K ADVANTAGE IMPLANT WITH HIFOCUS MID-SCALA ELECTRODE (HFMS) ELECTRODE (MODEL NUMBER CI-1500-04) AND FOR THE INTRODUCTION OF A REUSABLE INSTRUMENT KIT (MODEL NUMBER CI-4508).

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S109
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2015-04-14
Decision code: APPR
Date received: 2014-04-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A LABELING/PACKAGING CHANGE TO THE HIRES 90K ADVANTAGE IMPLANT WITH HIFOCUS MID-SCALA ELECTRODE (HFMS) ELECTRODE (MODEL NUMBER CI-1500-04) AND FOR THE INTRODUCTION OF A REUSABLE INSTRUMENT KIT (MODEL NUMBER CI-4508).