Sculptra and Sculptra Aesthetic

FDA Premarket Approval P030050 S036

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Moving the processes of filling, freeze drying, and capping into alternate cleanrooms.

DeviceSculptra and Sculptra Aesthetic
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantQ-Med AB
Date Received2021-04-01
Decision Date2021-04-28
PMAP030050
SupplementS036
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Q-Med AB seminariegatan 21 uppsala SE-75-752-

Supplemental Filings

Supplement NumberDateSupplement Type
P030050Original Filing
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 IDPMASupp
20302995961057 P030050 000
20302995961040 P030050 000
20302995961033 P030050 000
20302995961064 P030050 002

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