PMA P130016S052

Device: Nucleus Hybrid L24 Cochlear Implant System
Applicant: Cochlear Americas
PMA number: P130016
Supplement: S052
Product code: PGQ
Decision date: 2023-11-17
Classification: Ear, Nose, Throat
Generic name: Cochlear implant with combined electrical stimulation and acoustic amplification
Approval order statement: Approval for modification of the approved labeling for the Nucleus® Hybrid™ L24 Cochlear Implant System to reflect the findings of the Post-Approval Study: New Enrollment Study (P130016/PAS002).

Current openFDA PMA Record#

Device: Nucleus Hybrid L24 Cochlear Implant System
Applicant: Cochlear Americas
PMA number: P130016
Supplement: S052
Product code: PGQ
Generic name: Cochlear implant with combined electrical stimulation and acoustic amplification
Decision date: 2023-11-17
Decision code: APPR
Date received: 2023-03-13
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for modification of the approved labeling for the Nucleus® Hybrid™ L24 Cochlear Implant System to reflect the findings of the Post-Approval Study: New Enrollment Study (P130016/PAS002).