PMA P890027S059
- Device
- Nucleus N22 Cochlear Implant Systems
- Applicant
- Cochlear Americas
- PMA number
- P890027
- Supplement
- S059
- Product code
- MCM
- Decision date
- 2017-11-17
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval order for the remote programing of Nucleus N22 Cochlear Implant System using telehealth technology should be issued.
Current openFDA PMA Record#
- Device
- Nucleus N22 Cochlear Implant Systems
- Applicant
- Cochlear Americas
- PMA number
- P890027
- Supplement
- S059
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2017-11-17
- Decision code
- APPR
- Date received
- 2017-05-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval order for the remote programing of Nucleus N22 Cochlear Implant System using telehealth technology should be issued.