PMA P130016S009
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S009
- Product code
- PGQ
- Decision date
- 2015-04-08
- 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 FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: 1) ADDITION OF THE IMPLANT EAR, ELECTRIC ONLY TEST CONDITION, AND 2) MODIFICATION OF THE TESTING SCHEDULE TO INCLUDE A TIERED APPROACH.
Current openFDA PMA Record#
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S009
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2015-04-08
- Decision code
- APPR
- Date received
- 2014-09-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: 1) ADDITION OF THE IMPLANT EAR, ELECTRIC ONLY TEST CONDITION, AND 2) MODIFICATION OF THE TESTING SCHEDULE TO INCLUDE A TIERED APPROACH.