PMA P970051S213
- Device
- Nucleus® 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S213
- Product code
- MCM
- Decision date
- 2022-08-09
- Generic name
- Implant, cochlear
- Approval order statement
- Additional laser welding system for the top shell to shield welding process.
Current openFDA PMA Record#
- Device
- Nucleus® 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S213
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2022-08-09
- Decision code
- OK30
- Date received
- 2022-07-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional laser welding system for the top shell to shield welding process.