PMA P090018
- Device
- Esteem®
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S041
- Product code
- OAF
- Decision date
- 2026-06-03
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- approval for the manufacturing equipment change affecting the hermetic sealing process of the Esteem® Sensor and Driver
Current openFDA PMA Record#
- Device
- Esteem®
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S043
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2026-06-03
- Decision code
- OK30
- Date received
- 2026-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for the manufacturing equipment change affecting the hermetic sealing process of the Esteem® Sensor and Driver