PMA P090018S042
- Device
- Esteem®
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S042
- Product code
- OAF
- Decision date
- 2026-05-21
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- Approval for a new laser reflector material used with Laser Doppler Vibrometer (LDV) measurements during the implantation procedure.
Current openFDA PMA Record#
- Device
- Esteem®
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S042
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2026-05-21
- Decision code
- APPR
- Date received
- 2026-02-19
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new laser reflector material used with Laser Doppler Vibrometer (LDV) measurements during the implantation procedure.