PMA P000025S103

Device: Mi1210 SYNCHRONY ST Cochlear Implant
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S103
Product code: MCM
Decision date: 2019-01-22
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: Approval for the Mi1210 SYNCHRONY ST Cochlear Implant +Standard, +Medium, +Compressed, +FLEXSOFT, +FLEX24, +FLEX28 (for non-EAS patients), the Mi1210 SYNCHRONY ST Cochlear Implant +FLEX20, +FLEX24 (for EAS patients), the Mi1210 Implant Template, and associated surgical accessories.

Current openFDA PMA Record#

Device: Mi1210 SYNCHRONY ST Cochlear Implant
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S103
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2019-01-22
Decision code: APPR
Date received: 2018-07-18
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the Mi1210 SYNCHRONY ST Cochlear Implant +Standard, +Medium, +Compressed, +FLEXSOFT, +FLEX24, +FLEX28 (for non-EAS patients), the Mi1210 SYNCHRONY ST Cochlear Implant +FLEX20, +FLEX24 (for EAS patients), the Mi1210 Implant Template, and associated surgical accessories.