CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE
FDA premarket approval P960058/S004 · decided 1998-05-28
Approval details
- PMA number
- P960058
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE
- Applicant
- Advanced Bionics
- Date received
- 1998-03-30
- Decision date
- 1998-05-28
- Days to decision
- 59 days
- Decision code
- APPR
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- 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.
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