CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) HIFOCUS ELECTRODE
FDA premarket approval P940022/S014 · decided 2000-07-13
Approval details
- PMA number
- P940022
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) HIFOCUS ELECTRODE
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics Corp.
- Date received
- 2000-03-22
- Decision date
- 2000-07-13
- Days to decision
- 113 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT HIFOCUS ELECTRODE FOR POST-LINGUAL SEVERE TO PROFOUND HEARING LOSS WHERE LIMITED BENEFIT HAS BEEN OBTAINED WITH THE USE OF HEARING AIDS.
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