General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on April 27, 2011, from 8 a.m. to 6 p.m.

Agenda: On April 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application supplement for RESTYLANE, sponsored by Medicis Aesthetics, Inc. RESTYLANE is currently approved for mid- to deep-dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The sponsor is requesting an expanded indication, to include use of RESTYLANE for augmentation of the lips.