NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH NUCLEUS 24 CONTOUR ADVANCE/SOFTIP II ELECTRODE AND INSERTION TOOL
FDA premarket approval P970051/S027 · decided 2004-05-18
Approval details
- PMA number
- P970051
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH NUCLEUS 24 CONTOUR ADVANCE/SOFTIP II ELECTRODE AND INSERTION TOOL
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2003-10-06
- Decision date
- 2004-05-18
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR AN ELECTRODE INSERTION TOOL TO FACILITATE PLACEMENT OF THE ELECTRODE INTO THE COCHLEA AS WELL AS MINOR MODIFICATIONS TO THE SOFTIP ELECTRODE TO OPTIMIZE ITS INTERACTION WITH THE INSERTION TOOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INSERTION TOOL FOR THE NUCLEUS 24 CONTOUR ADVANCE/SOFTIP ELECTRODE II.
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