Nucleus 22 Cochlear Implant System
FDA premarket approval P840024/S089 · decided 2017-12-14
Approval details
- PMA number
- P840024
- Supplement
- S089
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Nucleus 22 Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2017-02-09
- Decision date
- 2017-12-14
- Days to decision
- 308 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a change in clinical guidance for programming Nucleus cochlear implant recipients in bipolar mode.
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