PMA P090018S030
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S030
- Product code
- OAF
- Decision date
- 2016-03-18
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- Approval of the following changes to the post-approval study for your device:change in sample size, removal of blinded audiologists, removal of requirement for x-ray ofimplanted device, change in follow-up point of evaluation and data gathering for safety objective.
Current openFDA PMA Record#
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S030
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2016-03-18
- Decision code
- APPR
- Date received
- 2015-09-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the following changes to the post-approval study for your device:change in sample size, removal of blinded audiologists, removal of requirement for x-ray ofimplanted device, change in follow-up point of evaluation and data gathering for safety objective.