PMA P970051S180
- Device
- Nucleus C1532 Cochlear Implant
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S180
- Product code
- MCM
- Decision date
- 2018-07-11
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for labeling enhancements for the Nucleus CI532 Cochlear Implant.
Current openFDA PMA Record#
- Device
- Nucleus C1532 Cochlear Implant
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S180
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2018-07-11
- Decision code
- APPR
- Date received
- 2018-06-11
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling enhancements for the Nucleus CI532 Cochlear Implant.