PMA P970051S168
- Device
- Nucleus 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S168
- Product code
- MCM
- Decision date
- 2017-08-23
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Move the manufacturing of the CI500 series Sterile Replacement Magnet and the Non-Magnetic Plug to the Macquarie site where similar manufacturing processes occur.
Current openFDA PMA Record#
- Device
- Nucleus 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S168
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2017-08-23
- Decision code
- OK30
- Date received
- 2017-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Move the manufacturing of the CI500 series Sterile Replacement Magnet and the Non-Magnetic Plug to the Macquarie site where similar manufacturing processes occur.