PMA P970051S160
- Device
- Nucleus 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S160
- Product code
- MCM
- Decision date
- 2017-05-09
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Transfer of the Arburg 220S Molding Machine (CP800/CP900 Injection Molding Tool System) from the Lane Cove manufacturing site to the Macquarie manufacturing site.
Current openFDA PMA Record#
- Device
- Nucleus 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S160
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2017-05-09
- Decision code
- OK30
- Date received
- 2017-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of the Arburg 220S Molding Machine (CP800/CP900 Injection Molding Tool System) from the Lane Cove manufacturing site to the Macquarie manufacturing site.