NUCLEUS 24-COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S035 · decided 2006-01-27
Approval details
- PMA number
- P970051
- Supplement
- S035
- 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
- 2005-12-20
- Decision date
- 2006-01-27
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE ADDITION OF A THIN PARYLENE COATING TO THE PLATINUM STYLET THAT SUPPORTS THE CONTOUR ADVANCE ELECTRODE ARRAY, PRIOR TO AND DURING THE INSERTION PROCESS.
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