CLARION MULTI STRATEGY COCHLEAR IMPLANT SYSTEM
FDA premarket approval P960058/S021 · decided 2002-06-06
Approval details
- PMA number
- P960058
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION MULTI STRATEGY COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2002-05-28
- Decision date
- 2002-06-06
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE CPI SWITCH BOX (FORMERLY A/B SWITCH BOX). THE CPI SWITCH BOX IS AN INTERFACE BOX TO FACILITATE THE CONNECTION OF TWO PROGRAMMING CABLES TO THE EXISTING CPI (CLINICIAN'S PROGRAMMING INTERFACE).
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