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: S002
• Date Received: 08/19/2009
• Decision Date: 10/08/2009
• Product Code: MPV [ Registered Establishments with MPV ]
• Advisory Committee: Ear Nose & Throat
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: labeling change - trade name
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval to change the labeling with a new product name, maxum system.