PMA P130016S049
- Device
- Nucleus Hybrid L24 Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S049
- Product code
- PGQ
- Decision date
- 2022-06-16
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Nucleus Hybrid L24 Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S049
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2022-06-16
- Decision code
- APPR
- Date received
- 2022-05-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.