PMA P130016S021
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S021
- Product code
- PGQ
- Decision date
- 2017-09-22
- 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 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
- S021
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2017-09-22
- Decision code
- APPR
- Date received
- 2016-10-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.