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: SCULPTRA AESTHETIC
• Classification Name: implant, dermal, for aesthetic use
• Generic Name: injectable poly-l-lactic acid
• Applicant: SANOFI AVENTIS U.S. LLC
• PMA Number: P030050
• Supplement Number: S005
• Date Received: 08/19/2009
• Decision Date: 03/05/2010
• Product Code: LMH [ Registered Establishments with LMH ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

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