Public Health Service

Abstract

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement for SCULPTRA Aesthetic. The device is indicated for use in immune-competent people as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate. The PMA supplement is approved. You may begin commercial distribution of the device as modified in accordance with the conditions described below and in the "Conditions of Approval" (enclosed).