PMA P130016S002
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S002
- Product code
- PGQ
- Decision date
- 2014-07-01
- 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 AN MR INDICATION AT 1.5 TESLA UNDER SPECIFIC SCANNING CONDITIONS WITH THE MAGNET SURGICALLY REMOVED PRIOR TO THE MR SCAN, FOR THE HYBRID L24 IMPLANT SYSTEM.
Current openFDA PMA Record#
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S002
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2014-07-01
- Decision code
- APPR
- Date received
- 2014-04-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR AN MR INDICATION AT 1.5 TESLA UNDER SPECIFIC SCANNING CONDITIONS WITH THE MAGNET SURGICALLY REMOVED PRIOR TO THE MR SCAN, FOR THE HYBRID L24 IMPLANT SYSTEM.