PMA P130016S012
- Device
- NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S012
- Product code
- PGQ
- Decision date
- 2016-07-08
- 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 requested for 1) a change in indications to allow MRI of implant recipients at 1.5T with the implant magnet in place for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST) provided that a Cochlear-supplied MRI kit is used; 2) a change in indications to allow MRI of implant recipients at 3.0T with the implant magnet removed for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST); and 3) consolidation of MRI-related labeling into a single document that provides appropriate instructions for the following Cochlear-manufactured implants: CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), CI24RE(ST), CI24R(CA), CI24R(CS), CI24R(ST), CI24M, and CI 11+11+2M.
Current openFDA PMA Record#
- Device
- NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S012
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2016-07-08
- Decision code
- APPR
- Date received
- 2015-11-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval requested for 1) a change in indications to allow MRI of implant recipients at 1.5T with the implant magnet in place for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST) provided that a Cochlear-supplied MRI kit is used; 2) a change in indications to allow MRI of implant recipients at 3.0T with the implant magnet removed for CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), and CI24RE(ST); and 3) consolidation of MRI-related labeling into a single document that provides appropriate instructions for the following Cochlear-manufactured implants: CI512, CI522, CI532, CI422, CI24REH, CI24RE(CA), CI24RE(ST), CI24R(CA), CI24R(CS), CI24R(ST), CI24M, and CI 11+11+2M.