PMA P000025S090

Device
Mi1200 Magnet Assembly
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S090
Product code
MCM
Decision date
2016-11-22
Classification
Implant, Cochlear
Generic name
Implant, cochlear
Approval order statement
Approval for the addition of a spring ring inside the magnet housing of the implanted Mi1200 Magnet Assembly.

Current openFDA PMA Record#

Device
Mi1200 Magnet Assembly
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S090
Product code
MCM
Generic name
Implant, cochlear
Decision date
2016-11-22
Decision code
APPR
Date received
2016-08-29
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the addition of a spring ring inside the magnet housing of the implanted Mi1200 Magnet Assembly.