Nucleus 24 Cochlear Implant System
FDA premarket approval P970051/S205 · decided 2022-01-10
Approval details
- PMA number
- P970051
- Supplement
- S205
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Nucleus 24 Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2021-05-28
- Decision date
- 2022-01-10
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for the Cochlear Nucleus 24 cochlear implant system. The device is indicated for individuals with unilateral hearing loss who meet the following criteria:1) Individuals 5 years or older who have one ear with a severe to profound sensorineural hearing loss and obtain limited benefit from an appropriately fitted unilateral hearing device and one ear with normal or near normal hearing. a) In the ear to be implanted, a severe to profound sensorineural hearing loss defined as a PTA at 500 Hz
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