Neuro Cochlear Implant System
FDA premarket approval P200021/S009 · decided 2021-11-04
Approval details
- PMA number
- P200021
- Supplement
- S009
- 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
- 2021-10-08
- Decision date
- 2021-11-04
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- 06220 Vallauris
- Statement
- Changes to production test software programs and stimulation chip testing.
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