Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: MAXUM SYSTEM
• Classification Name: implant, hearing, active, middle ear, partially implanted
• Generic Name: implantable middle ear hearing device
• Applicant: OTOTRONIX, LLC
• PMA Number: P010023
• Supplement Number: S008
• Date Received: 02/01/2011
• Decision Date: 03/02/2011
• Product Code: MPV [ Registered Establishments with MPV ]
• Advisory Committee: Ear Nose & Throat
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change to the ipc shell fabrication process.