PMA P000025

Device: MED-EL Cochlear Implant
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S123
Product code: MCM
Decision date: 2026-01-23
Generic name: Implant, cochlear
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P000025/S134 Based upon the information submitted, the PMA supplement is approved.

Current openFDA PMA Record#

Device: MED-EL Cochlear Implant
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S137
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2026-01-23
Decision code: APPR
Date received: 2025-12-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P000025/S134 Based upon the information submitted, the PMA supplement is approved.