PMA P960058S004

Device: CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S004
Decision date: 1998-05-28
Approval order statement: Approval for the modified CLARION device in which the implantable cochlear stimulator (ICS) housing is made of zirconia instead of alumina. The new housing configuration is to be referred to as the CIM 3.

Current openFDA PMA Record#

Device: CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S004
Decision date: 1998-05-28
Decision code: APPR
Date received: 1998-03-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the modified CLARION device in which the implantable cochlear stimulator (ICS) housing is made of zirconia instead of alumina. The new housing configuration is to be referred to as the CIM 3.