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: BELOTERO BALANCE
• Classification Name: implant, dermal, for aesthetic use
• Applicant: MERZ AESTHETICS, INC.
• PMA Number: P090016
• Supplement Number: S001
• Date Received: 12/14/2011
• Decision Date: 05/01/2012
• Product Code: LMH [ Registered Establishments with LMH ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study protocol.