PMA P890027S058
- Device
- Nucleus 22 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P890027
- Supplement
- S058
- Product code
- MCM
- Decision date
- 2017-12-14
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for a change in clinical guidance for programming Nucleus cochlear implant recipients in bipolar mode.
Current openFDA PMA Record#
- Device
- Nucleus 22 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P890027
- Supplement
- S058
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2017-12-14
- Decision code
- APPR
- Date received
- 2017-02-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change in clinical guidance for programming Nucleus cochlear implant recipients in bipolar mode.