PMA P090018S036
- Device
- Esteem
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S036
- Product code
- OAF
- Decision date
- 2017-06-09
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- New component supplier for the polyether ether ketone (PEEK) overmold component of the Esteem Model 7004/7010 Sensor assemblies and Model 7504/7510 Driver assemblies.
Current openFDA PMA Record#
- Device
- Esteem
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S036
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2017-06-09
- Decision code
- OK30
- Date received
- 2017-05-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New component supplier for the polyether ether ketone (PEEK) overmold component of the Esteem Model 7004/7010 Sensor assemblies and Model 7504/7510 Driver assemblies.