PMA P960058S028

Device: CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S028
Product code: MCM
Decision date: 2002-11-25
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR MINOR CHANGES TO THE HIFOCUS ELECTRODE TO BETTER FACILITATE THE PACKING OF THE COCHLEOSTOMY AND ELECTRODE INSERTION. SPECIFICALLY, THE CHANGES ARE TO MOVE THE OFFSET REGION APPROXIMATELY 3 MM FURTHER AWAY FROM THE CURRENT LOCATION.

Current openFDA PMA Record#

Device: CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S028
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2002-11-25
Decision code: APPR
Date received: 2002-11-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MINOR CHANGES TO THE HIFOCUS ELECTRODE TO BETTER FACILITATE THE PACKING OF THE COCHLEOSTOMY AND ELECTRODE INSERTION. SPECIFICALLY, THE CHANGES ARE TO MOVE THE OFFSET REGION APPROXIMATELY 3 MM FURTHER AWAY FROM THE CURRENT LOCATION.