Approved Wrinkle Fillers

FDA approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the wrinkle fillers when injected into the nasolabial folds.

Additional information about the data reviewed by FDA for a FDA approved dermal filler can be found in the Summary of Safety and Effectiveness Data.

Product Code = LMH

Trade Name	Material	Applicant	PMA Number	Decision Date	Additional Information
ARTEFILL	Polymethylmethacrylate Beads, Collagen and Lidocaine.	Suneva Medical, Inc.	P020012	10/27/2006	New Device Approval Professional Labeling
RESTYLANE INJECTABLE GEL	Hyaluronic Acid	Q-med Ab	P020023	12/12/2003	New Device Approval Professional Labeling
HYLAFORM (HYLAN B GEL)	Modified hylauronic acid derived from a bird (avian) source	Genzyme Biosurgery	P030032	4/22/2004	New Device Approval Patient Labeling Professional Labeling
CAPTIQUE INJECTABLE GEL	Hyaluraonic Acid	Genzyme Biosurgery	P030032 S002	11/12/2004
PREVELLE SILK	Hyaluraonic Acid with Lidocaine	Genzyme Biosurgery	P030032 S007	2/26/2008
SCULPTRA	Poly-L-Lactic Acid (PLLA)	Sanofi Aventis U.S.	P030050	8/3/2004	New Device Approval Patient Labeling Professional Labeling
SCULPTRA AESTHETIC	Poly-L-Lactic Acid (PLLA)	Sanofi Aventis U.S.	P030050 S002	7/28/2009	New Device Approval Professional Labeling
RESTYLANE INJECTABLE GEL	Hyaluraonic Acid	Medicis Aesthetics H	P040024	3/25/2005	New Device Approval Professional Labeling
ELEVESS	Hyaluraonic Acid with Lidocaine	Anika Therapeutics	P050033	12/20/2006	New Device Approval Professional Labeling
RADIESSE 1.3CC AND 0.3CC	Hydroxylapatite	Bioform Medical, Inc	P050037	12/22/2006	New Device Approval Professional Labeling
JUVEDERM 24HV, JUVEDERM 3	Hyaluraonic Acid	Allergan	P050047	6/2/2006	New Device Approval Patient Labeling Professional Labeling
RADIESSE 1.3CC AND 0.3CC	Hydroxylapatite	Bioform Medical, Inc	P050052	12/22/2006	New Device Approval Professional Labeling
EVOLENCE COLLAGEN FILLER	Collagen	Colbar Lifescience l	P070013	6/27/2008	New Device Approval Professional Labeling
ZYDERM COLLAGEN IMPLANT	Collagen	Allergan	P800022	7/22/1981
ZYPLAST(R)	Collagen	Collagen Corp.	P800022 S011	6/24/1985
COSMODERM 1 HUMAN-BASED C	Collagen	Inamed Corporation	P800022 S050	3/11/2003	New Device Approval Professional Labeling
COSMODERM AND COSMOPLAST	Collagen	Inamed Corporation	P800022 S052	5/11/2004
FIBREL	Collagen	Serono Laboratories	P850053 S001	7/18/1988