PMA P130016S053
- Device
- Nucleus® Hybrid™ L24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S053
- Product code
- PGQ
- Decision date
- 2023-10-13
- Classification
- Ear, Nose, Throat
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Approval order statement
- approval for a labeling change to the Cochlear Nucleus MRI Kit
Current openFDA PMA Record#
- Device
- Nucleus® Hybrid™ L24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S053
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2023-10-13
- Decision code
- APPR
- Date received
- 2023-09-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for a labeling change to the Cochlear Nucleus MRI Kit