NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S038 · decided 2006-06-14
Approval details
- PMA number
- P970051
- Supplement
- S038
- 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
- 2006-04-21
- Decision date
- 2006-06-14
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR 1) VERSION 1.3 OF THE CUSTOM SOUND PROGRAMMING SOFTWARE WHICH INCLUDES SOFTWARE MODIFICATIONS AND ENHANCEMENTS WHICH WILL ENABLE RECIPIENTS OF THE PREVIOUS GENERATION NUCLEUS 24 COCHLEAR IMPLANTS TO USE THE LATEST APPROVED FREEDOM SPEECH PROCESSOR, AND 2) FREEDOM PROCESSOR FIRMWARE CHANGES RELATED TO THE PROCESSORS LIQUID-CRYSTAL DISPLAY (LCD).
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