CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE
FDA premarket approval P940022/S004 · decided 1998-03-17
Approval details
- PMA number
- P940022
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE
- Applicant
- Advanced Bionics Corp.
- Date received
- 1997-12-23
- Decision date
- 1998-03-17
- Days to decision
- 84 days
- Decision code
- APPR
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval of a modified ICS lead electrode, i.e., the Flex Lead Electrode.
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