PMA P200021S001
- Device
- Neuro Cochlear Implant System
- Applicant
- Oticon Medical
- PMA number
- P200021
- Supplement
- S001
- Product code
- MCM
- Decision date
- 2021-08-20
- Generic name
- Implant, cochlear
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Neuro Cochlear Implant System
- Applicant
- Oticon Medical
- PMA number
- P200021
- Supplement
- S001
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2021-08-20
- Decision code
- APPR
- Date received
- 2021-07-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.