CLARION CII BIONIC EAR SYSTEM
FDA premarket approval P960058/S029 · decided 2003-02-04
Approval details
- PMA number
- P960058
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION CII BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2003-01-13
- Decision date
- 2003-02-04
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR AN OPTIONAL, ADJUNCT SOFTWARE [NEURAL RESPONSE IMAGING (NRI)] TO IMPLEMENT A CAPABILITY TO MEASURE AND RECORD A NEURAL RESPONSE USING THE SIGNAL GENERATED AND DETECTED BY THE IMPLANT ELECTRONICS.
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