PMA P010023S004

Device: MAXUM SYSTEM
Applicant: Ototronix, LLC
PMA number: P010023
Supplement: S004
Product code: MPV
Decision date: 2011-04-08
Generic name: Implant, hearing, active, middle ear, partially implanted
Approval order statement: APPROVAL FOR THE CHANGE TO A DIGITAL PROCESSOR IN THE EXTERNAL INTEGRATED PROCESSOR AND COIL (IPC). THE MAXUM DIGITAL IPC REPLACES THE ANALOG PROCESSOR WITH A STANDARD COMMERCIAL DIGITAL PROCESSOR INTENDED FOR HEARING AID USE.

Current openFDA PMA Record#

Device: MAXUM SYSTEM
Applicant: Ototronix, LLC
PMA number: P010023
Supplement: S004
Product code: MPV
Generic name: Implant, hearing, active, middle ear, partially implanted
Decision date: 2011-04-08
Decision code: APPR
Date received: 2010-07-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE CHANGE TO A DIGITAL PROCESSOR IN THE EXTERNAL INTEGRATED PROCESSOR AND COIL (IPC). THE MAXUM DIGITAL IPC REPLACES THE ANALOG PROCESSOR WITH A STANDARD COMMERCIAL DIGITAL PROCESSOR INTENDED FOR HEARING AID USE.