Nucleus CI522 Cochlear Implant, Nucleus CI532 Cochlear Implant, Nucleus CI622 Cochlear Implant, Nucleus CI624 Cochlear I
FDA premarket approval P970051/S219 · decided 2023-07-14
Approval details
- PMA number
- P970051
- Supplement
- S219
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus CI522 Cochlear Implant, Nucleus CI532 Cochlear Implant, Nucleus CI622 Cochlear Implant, Nucleus CI624 Cochlear I
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2023-06-15
- Decision date
- 2023-07-14
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Changes to the coating material and deposition process used on electrode molding tools.
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