PMA P200021

Device: Neuro Cochlear Implant System (NCIS)
Applicant: Oticon Medical
PMA number: P200021
Supplement: S014
Product code: MCM
Decision date: 2022-11-04
Generic name: Implant, cochlear
Approval order statement: Approval for increased temperature control of the brazing process of the implant assembly and adjustments to the in-process control methods for detecting hermeticity of the implant, for the Neuro Zti implant, as per the approval letter.

Current openFDA PMA Record#

Device: Neuro Cochlear Implant System (NCIS)
Applicant: Oticon Medical
PMA number: P200021
Supplement: S013
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2022-11-04
Decision code: APPR
Date received: 2022-05-13
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for increased temperature control of the brazing process of the implant assembly and adjustments to the in-process control methods for detecting hermeticity of the implant, for the Neuro Zti implant, as per the approval letter.