PMA P000025S104

Device: MED-EL Cochlear Implant System
Applicant: Med-El Corp.
Product code: MCM
Decision date: 2019-07-19
Generic name: Implant, cochlear
Approval order statement: Approval for expanding the cochlear implantation indications to include patients 5 years and above with single sided deafness (SSD) and asymmetric hearing loss (AHL) who have profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear.

Current openFDA PMA Record#

Device: MED-EL Cochlear Implant System
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S104
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2019-07-19
Decision code: APPR
Date received: 2018-07-30
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for expanding the cochlear implantation indications to include patients 5 years and above with single sided deafness (SSD) and asymmetric hearing loss (AHL) who have profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear.