NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S048 · decided 2009-08-28
Approval details
- PMA number
- P970051
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2008-11-25
- Decision date
- 2009-08-28
- Days to decision
- 276 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE CI512 AND CI513 COCHLEAR IMPLANTS. THE CI512 AND CI513 IMPLANTS REPRESENT MODIFICATIONS TO THE NUCLEUS FREEDOM COCHLEAR IMPLANT (ALSO CALLED THE CI24RE).
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