Restylane Refyne, Restylane Defyne

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P140029 S020

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

To remove window/wall sections and decommissioned packaging equipment and to install a new door in an iso class 8 clean room

DeviceRestylane Refyne, Restylane Defyne
Classification NameImplant, Dermal, For Aesthetic Use
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantQ-Med AB
Date Received2019-08-15
Decision Date2019-09-13
PMAP140029
SupplementS020
Product CodeLMH
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Q-Med AB seminariegatan 21 uppsala S-752-7522

Supplemental Filings

Supplement NumberDateSupplement Type
P140029Original Filing
S047 2022-11-21 Special (immediate Track)
S046 2022-09-07 30-day Notice
S045
S044 2021-11-15 30-day Notice
S043 2021-11-05 30-day Notice
S042 2021-09-27 30-day Notice
S041
S040 2021-06-02 135 Review Track For 30-day Notice
S039
S038 2021-03-16 30-day Notice
S037 2021-03-15 30-day Notice
S036 2021-02-01 30-day Notice
S035
S034 2020-10-07 30-day Notice
S033
S032
S031
S030 2020-09-14 30-day Notice
S029
S028 2020-07-29 30-day Notice
S027
S026 2020-06-04 30-day Notice
S025 2020-04-21 Special (immediate Track)
S024 2020-02-18 30-day Notice
S023 2020-01-21 30-day Notice
S022
S021 2019-09-03 Panel Track
S020 2019-08-15 30-day Notice
S019
S018
S017 2019-05-17 Real-time Process
S016 2019-02-14 30-day Notice
S015 2018-10-22 30-day Notice
S014 2018-09-19 30-day Notice
S013 2018-08-23 30-day Notice
S012 2018-06-01 30-day Notice
S011 2018-05-25 30-day Notice
S010 2018-05-23 30-day Notice
S009 2018-05-18 30-day Notice
S008 2018-05-16 30-day Notice
S007 2018-04-26 Real-time Process
S006 2017-12-18 135 Review Track For 30-day Notice
S005
S004 2017-06-14 Normal 180 Day Track No User Fee
S003 2017-06-08 30-day Notice
S002
S001 2017-01-11 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
03770034301059 P140029 000
03770034301042 P140029 000
03770034301028 P140029 000
07331689115833 P140029 032
07331689115826 P140029 032

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