Cochlear Nucleus® CI632 cochlear implant with Slim Modiolar electrode, Cochlear Nucleus® CI532 cochlear implant with S
FDA premarket approval P970051/S228 · decided 2024-08-01
Approval details
- PMA number
- P970051
- Supplement
- S228
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cochlear Nucleus® CI632 cochlear implant with Slim Modiolar electrode, Cochlear Nucleus® CI532 cochlear implant with S
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2024-07-02
- Decision date
- 2024-08-01
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- approval for modifications to the EA32 electrode molding and lead forming manufacturing processes
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