PMA P130016S044
- Device
- Hybrid Implant System
- Applicant
- Cochlear Americas
- Product code
- PGQ
- Decision date
- 2020-12-30
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Approval order statement
- Approval for a new in-house terminal sterilization process to be used with a new sterilizer.
Current openFDA PMA Record#
- Device
- Hybrid Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S044
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- 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.