PMA P970051S209
- Device
- Nucleus® 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S209
- Product code
- MCM
- Decision date
- 2022-03-03
- Generic name
- Implant, cochlear
- Approval order statement
- Introduction of an alternate laser welding system to the current system, to perform hermitization hole welding in the implant assembly.
Current openFDA PMA Record#
- Device
- Nucleus® 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S209
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2022-03-03
- Decision code
- OK30
- Date received
- 2022-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of an alternate laser welding system to the current system, to perform hermitization hole welding in the implant assembly.