PMA P970051S200
- Device
- 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- Product code
- MCM
- Decision date
- 2020-12-30
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for a new in-house terminal sterilization process to be used with a new sterilizer.
Current openFDA PMA Record#
- Device
- 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S200
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2020-12-30
- Decision code
- APPR
- Date received
- 2020-10-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new in-house terminal sterilization process to be used with a new sterilizer.