BTE FIREFLY (PEDIATRIC)
FDA premarket approval P960058/S024 · decided 2002-09-23
Approval details
- PMA number
- P960058
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BTE FIREFLY (PEDIATRIC)
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- 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
- Valencia, 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.