Neuro Cochlear Implant System
FDA premarket approval P200021/S014 · decided 2022-06-17
Approval details
- PMA number
- P200021
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Neuro Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Oticon Medical
- Date received
- 2022-05-18
- Decision date
- 2022-06-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- 06220 Vallauris
- Statement
- Improved equipment and manufacturing workflow at the electronic assembly supplier; and (2 modification to the tooling used for feedthrough leak testing.
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