PMA P970051S237

Device: Cochlear™ Nucleus® System
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S237
Product code: MCM
Decision date: 2025-09-02
Classification: Ear, Nose, Throat
Generic name: Implant, cochlear
Approval order statement: This revision includes data from an IDE study (G190269) to complete the pediatric recruitment arm of this PAS. These additional data are from 23 subjects whose audiometric inclusion criteria overlap with the inclusion criteria for this PAS.

Current openFDA PMA Record#

Device: Cochlear™ Nucleus® System
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S237
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2025-09-02
Decision code: APPR
Date received: 2025-08-01
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: This revision includes data from an IDE study (G190269) to complete the pediatric recruitment arm of this PAS. These additional data are from 23 subjects whose audiometric inclusion criteria overlap with the inclusion criteria for this PAS.