Neuro Cochlear Implant System (NCIS)
FDA premarket approval P200021/S013 · decided 2022-11-04
Approval details
- PMA number
- P200021
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Neuro Cochlear Implant System (NCIS)
- Generic name
- Implant, cochlear
- Applicant
- Oticon Medical
- Date received
- 2022-05-13
- Decision date
- 2022-11-04
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- 06220 Vallauris
- Statement
- Approval for increased temperature control of the brazing process of the implant assembly and adjustments to the in-process control methods for detecting hermeticity of the implant, for the Neuro Zti implant, as per the approval letter.
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