Sculptra (injectable poly-L Lactic acid) and Sculptra Aesthetic (injectable poly-L Lactic acid)

FDA Premarket Approval P030050 S031

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

A change in the master protocol for requalification of the cobalt-60 irradiation source used for gamma sterilization of plla and replacement of cobalt-60 source and subsequent requalification performed in accordance with the revised protocol for sculptra and sculptra aesthetic

DeviceSculptra (injectable poly-L Lactic acid) and Sculptra Aesthetic (injectable poly-L Lactic acid)
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantQ-Med AB
Date Received2020-01-31
Decision Date2020-02-28
PMAP030050
SupplementS031
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
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
20302995961057 P030050 000
20302995961040 P030050 000
20302995961033 P030050 000
20302995961064 P030050 002
20302995961064 P030050 002

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