Juvéderm® Volbella™ XC

FDA Premarket Approval P110033 S062

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 labeling update in response to the approval condition #7 in fda’s approval order for p110033/s053, juvéderm® volbella™ xc, dated may 28, 2021.

DeviceJuvéderm® Volbella™ XC
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantAllergan
Date Received2021-06-29
Decision Date2021-09-10
PMAP110033
SupplementS062
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product Yes
Applicant Address Allergan 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
P110033Original Filing
S062 2021-06-29 Normal 180 Day Track No User Fee
S061 2021-06-29 30-day Notice
S060 2021-05-27 Special (immediate Track)
S059
S058
S057 2020-10-30 Special (immediate Track)
S056 2020-09-29 30-day Notice
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
10888628034471 P110033 020
10888628032446 P110033 023
10888628043565 P110033 031
10888628043541 P110033 031

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