PMA P090018S037
- Device
- Esteem Totally Implantable Hearing Device
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S037
- Product code
- OAF
- Decision date
- 2018-07-31
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- Approval for MR Conditional Labeling for the Esteem System.
Current openFDA PMA Record#
- Device
- Esteem Totally Implantable Hearing Device
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S037
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2018-07-31
- Decision code
- APPR
- Date received
- 2018-05-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for MR Conditional Labeling for the Esteem System.