PMA P970051S196
- Device
- Nucleus 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S196
- Product code
- MCM
- Decision date
- 2020-03-18
- Generic name
- Implant, cochlear
- Approval order statement
- Existing Cochlear manufacturing site in Kuala Lumpur, Malaysia, to expand their capacity to manufacture the Kanso ® CP950 Sound Processor.
Current openFDA PMA Record#
- Device
- Nucleus 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S196
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2020-03-18
- Decision code
- OK30
- Date received
- 2020-02-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Existing Cochlear manufacturing site in Kuala Lumpur, Malaysia, to expand their capacity to manufacture the Kanso ® CP950 Sound Processor.