CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT
FDA premarket approval P940022/S025 · decided 2002-09-23
Approval details
- PMA number
- P940022
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics Corp.
- Date received
- 2002-09-19
- Decision date
- 2002-09-23
- Days to decision
- 4 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR CHANGING THE PRODUCT NAME OF THE HIRES SOFTWARE, MODEL NUMBER CI-6055. THE SOFTWARE WILL BE MARKETED UNDER THE TRADE NAME SOUNDWAVE PROFESSIONAL SUITE, MODEL NUMBER CI-6055, AND IS INDICATED FOR USE IN ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12 MONTHS TO 17 YEARS, 11-MONTHS OF AGE).
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