Juvéderm Vollure XC and Volbella XC

FDA Premarket Approval P110033 S055

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 revisions to the clinician labeling of juvéderm® ultra, juvéderm® ultra xc, juvéderm® ultra plus, juvéderm® ultra plus xc, juvéderm® vollure™ xc, and juvéderm® volbella™ xc to include updated safety information based on post marketing surveillance data.

DeviceJuvéderm Vollure XC and Volbella XC
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantAllergan
Date Received2020-06-19
Decision Date2020-07-17
PMAP110033
SupplementS055
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address Allergan 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
P110033Original Filing
S055 2020-06-19 Special (immediate Track)
S054 2020-04-24 30-day Notice
S053
S052 2019-12-20 Real-time Process
S051 2019-11-15 30-day Notice
S050 2019-09-20 30-day Notice
S049
S048 2019-07-29 30-day Notice
S047
S046 2019-05-28 Special (immediate Track)
S045 2019-04-10 30-day Notice
S044
S043 2019-03-07 Special (immediate Track)
S042
S041 2019-01-03 30-day Notice
S040
S039 2018-04-05 30-day Notice
S038 2018-04-02 30-day Notice
S037 2018-03-08 30-day Notice
S036 2018-01-22 30-day Notice
S035 2017-11-20 30-day Notice
S034 2017-10-24 30-day Notice
S033 2017-08-21 135 Review Track For 30-day Notice
S032
S031 2017-08-04 Real-time Process
S030 2017-05-18 30-day Notice
S029 2017-05-03 30-day Notice
S028 2017-03-20 135 Review Track For 30-day Notice
S027 2017-03-16 30-day Notice
S026 2017-02-09 135 Review Track For 30-day Notice
S025 2016-12-23 30-day Notice
S024 2016-11-21 30-day Notice
S023 2016-06-14 Real-time Process
S022 2016-06-09 135 Review Track For 30-day Notice
S021 2016-03-21 Normal 180 Day Track No User Fee
S020 2015-09-30 Panel Track
S019 2015-08-31 Special (immediate Track)
S018 2015-08-03 Panel Track
S017
S016 2015-05-11 30-day Notice
S015 2015-06-10 Real-time Process
S014 2015-04-28 30-day Notice
S013 2015-02-24 30-day Notice
S012 2014-11-03 Special (immediate Track)
S011 2014-07-28 135 Review Track For 30-day Notice
S010 2014-07-01 30-day Notice
S009 2014-05-27 30-day Notice
S008 2014-05-13 30-day Notice
S007 2014-05-01 135 Review Track For 30-day Notice
S006 2014-03-31 30-day Notice
S005 2014-03-20 30-day Notice
S004 2014-01-23 30-day Notice
S003 2014-01-14 30-day Notice
S002 2013-11-25 135 Review Track For 30-day Notice
S001 2013-11-06 30-day Notice

NIH GUDID Devices

Device IDPMASupp
30888628000012 P110033 000
30888628000012 P110033 000
10888628034471 P110033 020
10888628034471 P110033 020
10888628032446 P110033 023
10888628032446 P110033 023
10888628043541 P110033 031
10888628043565 P110033 031
10888628043541 P110033 031
10888628043565 P110033 031

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