PMA P090018S026
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S026
- Product code
- OAF
- Decision date
- 2014-08-21
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES THAT HAVE BEEN MADE TO THE ESTEEMCOMMANDER IN VERSION 3.0.
Current openFDA PMA Record#
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S026
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2014-08-21
- Decision code
- APPR
- Date received
- 2014-05-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES THAT HAVE BEEN MADE TO THE ESTEEMCOMMANDER IN VERSION 3.0.