PMA P130016S047

Device: Nucleus® Hybrid™ L24 Cochlear Implant System
Applicant: Cochlear Americas
PMA number: P130016
Supplement: S047
Product code: PGQ
Decision date: 2022-03-03
Generic name: Cochlear implant with combined electrical stimulation and acoustic amplification
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® Hybrid™ L24 Cochlear Implant System
Applicant: Cochlear Americas
PMA number: P130016
Supplement: S047
Product code: PGQ
Generic name: Cochlear implant with combined electrical stimulation and acoustic amplification
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.