PMA P010023S010

Device
MAXUM
Applicant
Ototronix, LLC
PMA number
P010023
Supplement
S010
Product code
MPV
Decision date
2013-09-13
Generic name
Implant, hearing, active, middle ear, partially implanted
Approval order statement
APPROVAL FOR USER INTERFACE SOFTWARE CHANGES AND PATIENT FITTING CHANGES TO THE OPTIMAX PROGRAMMER SOFTWARE.

Current openFDA PMA Record#

Device
MAXUM
Applicant
Ototronix, LLC
PMA number
P010023
Supplement
S010
Product code
MPV
Generic name
Implant, hearing, active, middle ear, partially implanted
Decision date
2013-09-13
Decision code
APPR
Date received
2013-06-13
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR USER INTERFACE SOFTWARE CHANGES AND PATIENT FITTING CHANGES TO THE OPTIMAX PROGRAMMER SOFTWARE.