Nucleus 24 Cochlear Implant System
FDA premarket approval P970051/S194 · decided 2019-12-13
Approval details
- PMA number
- P970051
- Supplement
- S194
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus 24 Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2019-11-13
- Decision date
- 2019-12-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Manufacturing change of the silicone overmoulding used in the CI500 Series Cochlear Implant and the ABI541 Auditory Brainstem Implant.
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