NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S097 · decided 2012-11-09
Approval details
- PMA number
- P970051
- Supplement
- S097
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2012-09-11
- Decision date
- 2012-11-09
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL TO INTRODUCE A REMOTE CONTROL (CR120) FOR USE WITH THENUCLEUS 5 (MODEL CP810) SOUND PROCESSOR FOR INTRAOPERATIVE USE TO CONDUCT IMPEDANCE AND AUTONRT, MEASUREMENTS THAT ARE COMMONLY USED DURING COCHLEAR IMPLANT SURGERY TO INDICATE THAT THE ELECTRODES ARE FUNCTIONING AND ARE STIMULATING NERVE TISSUE.
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