PMA P090018S028
- Device
- ESTEEM SYSTEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S028
- Product code
- OAF
- Decision date
- 2015-01-30
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- NEW SUPPLIER FOR THE HEADER COMPONENT OF THE SOUND PROCESSOR.
Current openFDA PMA Record#
- Device
- ESTEEM SYSTEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S028
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2015-01-30
- Decision code
- OK30
- Date received
- 2014-12-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NEW SUPPLIER FOR THE HEADER COMPONENT OF THE SOUND PROCESSOR.