Neuro Cochlear Implant System (NCIS)
FDA premarket approval P200021/S012 · decided 2022-05-27
Approval details
- PMA number
- P200021
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Neuro Cochlear Implant System (NCIS)
- Generic name
- Implant, cochlear
- Applicant
- Oticon Medical
- Date received
- 2022-04-29
- Decision date
- 2022-05-27
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- 06220 Vallauris
- Statement
- Approval of the changes (e.g., additional minor changes to the protocol to align with US sites routine practice reported to Oticon Medical in the course of study site recruitment) of the protocol for the post-approval study (PAS) protocol.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.