PMA P090018S032
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S032
- Product code
- OAF
- Decision date
- 2016-12-12
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- Approval for a manufacturing site located at Envoy Medical Corporation, 4875 White Bear Parkway, St Paul, Minnesota.
Current openFDA PMA Record#
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S032
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2016-12-12
- Decision code
- APPR
- Date received
- 2016-04-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Envoy Medical Corporation, 4875 White Bear Parkway, St Paul, Minnesota.