PMA P090018S038
- Device
- Esteem System
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S038
- Product code
- OAF
- Decision date
- 2019-09-26
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- Change in a component supplier for the Model 7010 Sensor and Model 7510 Driver transducers.
Current openFDA PMA Record#
- Device
- Esteem System
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S038
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2019-09-26
- Decision code
- OK30
- Date received
- 2019-08-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in a component supplier for the Model 7010 Sensor and Model 7510 Driver transducers.