RESTYLANE INJECTABLE GEL

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P040024 S045

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 changes in microbiological and environmental testing at the manufacturing sites in sweden.

DeviceRESTYLANE INJECTABLE GEL
Classification NameImplant, Dermal, For Aesthetic Use
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantQ-Med AB
Date Received2009-11-25
Decision Date2010-04-07
PMAP040024
SupplementS045
Product CodeLMH
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type135 Review Track For 30-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
P040024Original Filing
S136 2022-11-21 Special (immediate Track)
S135
S134 2022-09-07 30-day Notice
S133
S132
S131 2022-04-04 Real-time Process
S130 2021-11-17 30-day Notice
S129 2021-11-17 30-day Notice
S128 2021-11-15 30-day Notice
S127
S126 2021-07-28 30-day Notice
S125
S124
S123
S122
S121 2020-10-07 30-day Notice
S120 2020-09-14 30-day Notice
S119
S118 2020-01-28 30-day Notice
S117
S116 2019-07-10 Real-time Process
S115 2019-07-02 Real-time Process
S114
S113 2019-05-21 30-day Notice
S112
S111 2019-05-20 30-day Notice
S110 2019-04-18 30-day Notice
S109
S108
S107 2019-01-31 30-day Notice
S106
S105 2018-11-19 30-day Notice
S104
S103 2018-11-01 Normal 180 Day Track
S102 2018-07-06 30-day Notice
S101 2018-04-20 Normal 180 Day Track
S100 2017-10-24 30-day Notice
S099 2017-08-29 Panel Track
S098 2017-07-10 30-day Notice
S097 2017-07-03 30-day Notice
S096 2017-02-16 Normal 180 Day Track
S095 2016-12-13 135 Review Track For 30-day Notice
S094 2016-11-01 Special (immediate Track)
S093 2016-10-06 30-day Notice
S092 2016-08-29 135 Review Track For 30-day Notice
S091 2016-07-20 30-day Notice
S090 2016-01-22 135 Review Track For 30-day Notice
S089 2015-10-29 Special (immediate Track)
S088 2015-10-29 Special (immediate Track)
S087 2015-10-15 30-day Notice
S086 2015-09-18 135 Review Track For 30-day Notice
S085 2015-09-02 30-day Notice
S084 2015-09-02 30-day Notice
S083 2015-08-31 Real-time Process
S082 2015-08-28 Special (immediate Track)
S081 2015-08-18 30-day Notice
S080
S079 2015-02-12 Normal 180 Day Track
S078 2014-10-03 30-day Notice
S077 2014-07-09 30-day Notice
S076 2014-07-02 135 Review Track For 30-day Notice
S075 2014-06-05 30-day Notice
S074 2014-05-28 30-day Notice
S073 2014-05-01 Panel Track
S072 2013-10-21 Panel Track
S071 2013-09-26 30-day Notice
S070 2013-05-28 Normal 180 Day Track
S069
S068 2013-01-31 30-day Notice
S067
S066 2012-12-11 30-day Notice
S065 2012-12-04 Real-time Process
S064 2012-11-01 30-day Notice
S063
S062 2012-07-13 Real-time Process
S061 2012-07-10 30-day Notice
S060 2012-06-27 30-day Notice
S059 2012-04-25 30-day Notice
S058 2012-04-23 30-day Notice
S057
S056 2012-01-10 Panel Track
S055 2011-11-04 135 Review Track For 30-day Notice
S054 2011-07-21 30-day Notice
S053 2011-07-07 Normal 180 Day Track No User Fee
S052 2011-01-28 Normal 180 Day Track
S051 2010-12-01 Panel Track
S050 2010-10-22 135 Review Track For 30-day Notice
S049 2010-07-13 30-day Notice
S048
S047
S046 2010-03-08 30-day Notice
S045 2009-11-25 135 Review Track For 30-day Notice
S044 2009-10-01 30-day Notice
S043 2009-07-16 30-day Notice
S042 2009-07-08 30-day Notice
S041 2009-06-10 30-day Notice
S040 2009-05-13 30-day Notice
S039 2009-04-16 Normal 180 Day Track
S038 2009-03-25 30-day Notice
S037 2009-03-17 30-day Notice
S036 2009-03-11 30-day Notice
S035 2009-02-09 30-day Notice
S034 2009-02-02 30-day Notice
S033 2009-01-15 30-day Notice
S032 2008-12-31 30-day Notice
S031 2008-12-03 30-day Notice
S030 2008-11-26 30-day Notice
S029 2008-09-29 30-day Notice
S028 2008-09-22 30-day Notice
S027 2008-07-25 30-day Notice
S026 2008-06-27 Special (immediate Track)
S025 2008-06-23 30-day Notice
S024 2008-06-17 30-day Notice
S023 2008-06-09 Normal 180 Day Track
S022 2008-05-19 Special (immediate Track)
S021 2008-04-07 30-day Notice
S020 2008-03-13 30-day Notice
S019 2008-03-10 30-day Notice
S018 2008-02-07 135 Review Track For 30-day Notice
S017 2008-01-11 30-day Notice
S016 2007-10-31 135 Review Track For 30-day Notice
S015 2007-10-30 135 Review Track For 30-day Notice
S014
S013 2007-09-14 30-day Notice
S012 2007-08-21 Normal 180 Day Track No User Fee
S011 2007-06-19 30-day Notice
S010 2007-06-12 30-day Notice
S009 2007-05-11 30-day Notice
S008 2007-05-09 30-day Notice
S007 2006-05-15 30-day Notice
S006 2006-03-28 Panel Track
S005 2006-02-02 Special (immediate Track)
S004 2006-01-09 Special (immediate Track)
S003
S002 2005-06-24 Normal 180 Day Track No User Fee
S001 2005-06-16 30-day Notice

NIH GUDID Devices

Device IDPMASupp
07331689111668 P040024 000
07331689113709 P040024 000
03770034301035 P040024 000
07331689111651 P040024 000
00302995967147 P040024 000
00302995963248 P040024 000
03770034301066 P040024 000
07331689111675 P040024 006
07331689111682 P040024 006
07331689111736 P040024 039
07331689111705 P040024 039
07331689111699 P040024 039
07331689111743 P040024 039
07331689111750 P040024 039
07331689113815 P040024 039
07331689113792 P040024 039
07331689113822 P040024 039
07331689111767 P040024 049
07331689111774 P040024 049
07331689111712 P040024 054
07331689111729 P040024 054
07331689111170 P040024 072
00302995967352 P040024 072
07331689113952 P040024 072
07331689112153 P040024 072
07331689113945 P040024 072
07331689113938 P040024 073
07331689113921 P040024 073
07331689112542 P040024 073
07331689112535 P040024 073
07331689114027 P040024 073
07331689114010 P040024 073
00302995969141 P040024 131
00302995963255 P040024 131
00302995963262 P040024 131
00302995967079 P040024 131
00302995969134 P040024 131
00302995967154 P040024 131
00302995967161 P040024 131
00302995967376 P040024 131
00302995967369 P040024 131
07331689120219 P040024 135
07331689120028 P040024 135

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