FDA.reportPublic FDA data

PMA P000025S114

Device
Mi1260 SONATA 2 Cochlear Implant and Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant
Applicant
Med-El Corp.
Product code
MCM
Decision date
2020-09-25
Generic name
Implant, cochlear
Approval order statement
Approval for the 1) Mi1260 SONATA 2 (with S-Vector Magnet); 2) optional tool S-Vector Magnet Replacement Kit; and 3) new S-Vector Magnet for use with the approved Mi1250 SYNCHRONY 2 (PIN).

Current openFDA PMA Record#

Device
Mi1260 SONATA 2 Cochlear Implant and Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S114
Product code
MCM
Generic name
Implant, cochlear
Decision date
2020-09-25
Decision code
APPR
Date received
2020-03-30
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the 1) Mi1260 SONATA 2 (with S-Vector Magnet); 2) optional tool S-Vector Magnet Replacement Kit; and 3) new S-Vector Magnet for use with the approved Mi1250 SYNCHRONY 2 (PIN).