PMA P130016S050
- Device
- Nucleus® Hybrid™ L24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S050
- Product code
- PGQ
- Decision date
- 2022-08-09
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Approval order statement
- Additional laser welding system for the top shell to shield welding process.
Current openFDA PMA Record#
- Device
- Nucleus® Hybrid™ L24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S050
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- 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.