PMA P090018S001
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S001
- Product code
- OAF
- Decision date
- 2011-05-06
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- APPROVAL FOR THE LEAD DESIGN (MODEL 7004/7504 LEADS) AND LEAD MANUFACTURING SITE CHANGE (ENVOY MEDICAL CORP., ST. PAUL, MINNESOTA).
Current openFDA PMA Record#
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S001
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2011-05-06
- Decision code
- APPR
- Date received
- 2010-04-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE LEAD DESIGN (MODEL 7004/7504 LEADS) AND LEAD MANUFACTURING SITE CHANGE (ENVOY MEDICAL CORP., ST. PAUL, MINNESOTA).