DevicePMAs@therightstef:P030050_S014 JSONTXT 11 Projects

Approval for the revision of a precaution statement in your product label to state: sculptra aesthetic should only be used by a healthcare practitioner trained to correct shallow to deep nasolabial contour deficiencies and other facial wrinkles, in which deep dermal grid pattern (cross-hatch) injection technique is appropriate, after the healthcare practitioner is fully familiar with the product, was, product educational materials, and the entire package insert and patient labeling. The device, as modified, will be marketed under the trade name sculptra aesthetic and 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.