PMA P090018S016
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S016
- Product code
- OAF
- Decision date
- 2012-06-22
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- APPROVAL TO ADD NEW, PHYSICALLY SMALLER, SENSOR/ DRIVER MODELS TO THE ESTEEM FAMILY.
Current openFDA PMA Record#
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S016
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2012-06-22
- Decision code
- APPR
- Date received
- 2011-11-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO ADD NEW, PHYSICALLY SMALLER, SENSOR/ DRIVER MODELS TO THE ESTEEM FAMILY.