PMA P200021S012

Device: Neuro Cochlear Implant System (NCIS)
Applicant: Oticon Medical
PMA number: P200021
Supplement: S012
Product code: MCM
Decision date: 2022-05-27
Generic name: Implant, cochlear
Approval order statement: Approval of the changes (e.g., additional minor changes to the protocol to align with US sites routine practice reported to Oticon Medical in the course of study site recruitment) of the protocol for the post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device: Neuro Cochlear Implant System (NCIS)
Applicant: Oticon Medical
PMA number: P200021
Supplement: S012
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2022-05-27
Decision code: APPR
Date received: 2022-04-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the changes (e.g., additional minor changes to the protocol to align with US sites routine practice reported to Oticon Medical in the course of study site recruitment) of the protocol for the post-approval study (PAS) protocol.