PMA P970051S240

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S240
Product code: MCM
Decision date: 2025-12-19
Classification: Ear, Nose, Throat
Generic name: Implant, cochlear
Approval order statement: to implement an automated electrode welding process, in a controlled non-cleanroom environment, to replace the existing semi-automatic manual welding process for manufacturing electrode arrays in the CI532, CI632, and CI1032 cochlear implants

Current openFDA PMA Record#

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S240
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2025-12-19
Decision code: OK30
Date received: 2025-11-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement an automated electrode welding process, in a controlled non-cleanroom environment, to replace the existing semi-automatic manual welding process for manufacturing electrode arrays in the CI532, CI632, and CI1032 cochlear implants