SCULPTRA AND SCULPTRA AESTHETIC

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P030050

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for sculptra. The device is intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

• Device: SCULPTRA AND SCULPTRA AESTHETIC
• Classification Name: Implant, Dermal, For Aesthetic Use
• Generic Name: Implant, Dermal, For Aesthetic Use
• Applicant: Q-Med AB
• Date Received: 2003-12-01
• Decision Date: 2004-08-03
• Notice Date: 2004-08-09
• PMA: P030050
• Supplement: S
• Product Code: LMH
• Docket Number: 04M-0350
• Advisory Committee: General & Plastic Surgery
• Expedited Review: Yes
• Combination Product: No
• Applicant Address: Q-Med AB seminariegatan 21 uppsala SE-75-752-
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P030050		Original Filing
S038	2021-12-22	Normal 180 Day Track No User Fee
S037
S036	2021-04-01	30-day Notice
S035
S034
S033	2020-11-18	30-day Notice
S032
S031	2020-01-31	30-day Notice
S030	2020-01-30	30-day Notice
S029	2018-05-02	30-day Notice
S028	2017-12-05	Normal 180 Day Track No User Fee
S027	2017-11-20	30-day Notice
S026	2017-02-08	135 Review Track For 30-day Notice
S025	2016-07-08	Special (immediate Track)
S024	2016-06-10	30-day Notice
S023
S022	2014-07-17	135 Review Track For 30-day Notice
S021	2014-04-01	30-day Notice
S020	2014-01-22	30-day Notice
S019	2013-12-23	30-day Notice
S018	2013-07-22	30-day Notice
S017	2013-04-05	Normal 180 Day Track No User Fee
S016	2013-03-25	Normal 180 Day Track No User Fee
S015	2013-03-04	135 Review Track For 30-day Notice
S014	2012-12-20	Real-time Process
S013	2012-12-18	30-day Notice
S012
S011	2011-05-20	135 Review Track For 30-day Notice
S010	2011-03-25	30-day Notice
S009	2010-12-06	Normal 180 Day Track No User Fee
S008	2010-05-19	Normal 180 Day Track No User Fee
S007	2009-08-19	Normal 180 Day Track No User Fee
S006	2009-10-09	Real-time Process
S005	2009-08-19	Normal 180 Day Track No User Fee
S004	2008-12-17	Normal 180 Day Track No User Fee
S003	2008-03-11	Normal 180 Day Track No User Fee
S002	2006-07-28	Panel Track
S001	2004-10-04	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
20302995961057	P030050	000
20302995961040	P030050	000
20302995961033	P030050	000
03770034301127	P030050	000
20302995961064	P030050	002
00302995961084	P030050	034
00302995961077	P030050	034