PMA P130016S016
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S016
- Product code
- PGQ
- Decision date
- 2016-09-01
- Classification
- Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Approval order statement
- Approval for a new CochlearTM CP950 Kanso sound processor, which is an external component of both the Nucleus 24 Cochlear Implant System and the Nucleus HybridL24 Implant System.
Current openFDA PMA Record#
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S016
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2016-09-01
- Decision code
- APPR
- Date received
- 2016-02-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a new CochlearTM CP950 Kanso sound processor, which is an external component of both the Nucleus 24 Cochlear Implant System and the Nucleus HybridL24 Implant System.