PMA P090018S029
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S029
- Product code
- OAF
- Decision date
- 2015-06-19
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- APPROVAL FOR A CHANGE TO THE UV EPOXY MATERIAL IN THE HEADER CONNECTOR OF THE SOUND PROCESSOR AND FOR A NEW PLASMA PRE-TREATMENT STEP TO ENHANCE ADHESION OF THE SILICONE DIP COATING.
Current openFDA PMA Record#
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S029
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2015-06-19
- Decision code
- APPR
- Date received
- 2015-03-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE UV EPOXY MATERIAL IN THE HEADER CONNECTOR OF THE SOUND PROCESSOR AND FOR A NEW PLASMA PRE-TREATMENT STEP TO ENHANCE ADHESION OF THE SILICONE DIP COATING.