PMA P090018S012
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S012
- Product code
- OAF
- Decision date
- 2011-09-21
- Classification
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Approval order statement
- APPROVAL FOR CHANGING FROM THE USE OF FETAL BOVINE SERUM TO THE USE OF BOVINE CALF SERUM AS A MEDIA SUPPLEMENT FOR EXPANDING CELLS IN EXPANDED SURFACE ROLLER BOTTLES, I.E., THE CELL EXPANSION PROCESS.
Current openFDA PMA Record#
- Device
- ESTEEM
- Applicant
- Envoy Medical Corporation
- PMA number
- P090018
- Supplement
- S012
- Product code
- OAF
- Generic name
- Implant, hearing, active, middle ear, totally implanted
- Decision date
- 2011-09-21
- Decision code
- OK30
- Date received
- 2011-08-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGING FROM THE USE OF FETAL BOVINE SERUM TO THE USE OF BOVINE CALF SERUM AS A MEDIA SUPPLEMENT FOR EXPANDING CELLS IN EXPANDED SURFACE ROLLER BOTTLES, I.E., THE CELL EXPANSION PROCESS.