NUCLEUS 24 CONTOUR ADVANCE
FDA premarket approval P970051/S021 · decided 2002-11-22
Approval details
- PMA number
- P970051
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 CONTOUR ADVANCE
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2002-07-16
- Decision date
- 2002-11-22
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR MINOR DESIGN MODIFICATION TO THE CONTOUR 24 COCHLEAR IMPLANT ELECTRODE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTOUR SOFTIP ELECTRODE.
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