Nucleus® 22 Cochlear Implant System
FDA premarket approval P890027/S065 · decided 2024-05-31
Approval details
- PMA number
- P890027
- Supplement
- S065
- 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
- 2024-05-03
- Decision date
- 2024-05-31
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- labeling change for the Cochlear Surgical Processor
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