SCULPTRA AESTHETIC

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P030050 S014

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

Approval for the revision of a precaution statement in your product label to state: sculptra aesthetic should only be used by a healthcare practitioner trained to correct shallow to deep nasolabial contour deficiencies and other facial wrinkles, in which deep dermal grid pattern (cross-hatch) injection technique is appropriate, after the healthcare practitioner is fully familiar with the product, was, product educational materials, and the entire package insert and patient labeling. The device, as modified, will be marketed under the trade name sculptra aesthetic and is indicated for use in immune-competent people as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.

DeviceSCULPTRA AESTHETIC
Classification NameImplant, Dermal, For Aesthetic Use
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantQ-Med AB
Date Received2012-12-20
Decision Date2013-05-28
PMAP030050
SupplementS014
Product CodeLMH
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Q-Med AB seminariegatan 21 uppsala SE-75-752-

Supplemental Filings

Supplement NumberDateSupplement Type
P030050Original 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 IDPMASupp
20302995961057 P030050 000
20302995961040 P030050 000
20302995961033 P030050 000
20302995961064 P030050 002
00302995961084 P030050 034
00302995961077 P030050 034

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