Restylane Kysse Injectable Gel

FDA Premarket Approval P140029 S038

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

Revision of the criteria for the visual inspection of filled and sterilized syringes performed during manufacturing

DeviceRestylane Kysse Injectable Gel
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantQ-Med AB
Date Received2021-03-16
Decision Date2021-04-13
PMAP140029
SupplementS038
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
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

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.