BTE FIREFLY (ADULT)
FDA premarket approval P940022/S024 · decided 2002-09-23
Approval details
- PMA number
- P940022
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BTE FIREFLY (ADULT)
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics Corp.
- Date received
- 2002-09-16
- Decision date
- 2002-09-23
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE BTE FIREFLY, MODEL CI-5705. THIS DEVICE PROVIDES SYSTEM VERIFICATION CAPABILITY TO CLINICIANS AND PARENTS INCLUDING BATTERY CHARGE STATUS, SYSTEM LOCK STATUS, AND PROGRAM SLOT INFORMATION.
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