Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels

FDA Premarket Approval P140029 S028

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 change the sterilization validation approach to the overkill method/full cycle approach defined in iso 17665-1:2006 annex d4

DeviceRestylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantQ-Med AB
Date Received2020-07-29
Decision Date2020-08-28
PMAP140029
SupplementS028
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
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

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