PMA P970051S195
- Device
- Nucleus Cochlear Implant System (C124RE and C1500)
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S195
- Product code
- MCM
- Decision date
- 2020-02-21
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for changes to MR Conditional labeling for CI24REH, CI24RE and CI500 Series Cochlear Implants.
Current openFDA PMA Record#
- Device
- Nucleus Cochlear Implant System (C124RE and C1500)
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S195
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2020-02-21
- Decision code
- APPR
- Date received
- 2020-01-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to MR Conditional labeling for CI24REH, CI24RE and CI500 Series Cochlear Implants.