Restylane Refyne, Restylane Defyne Injectable Gels

FDA Premarket Approval P140029 S024

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 of restylane refyne and restylane defyne

DeviceRestylane Refyne, Restylane Defyne Injectable Gels
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantQ-Med AB
Date Received2020-02-18
Decision Date2020-03-19
PMAP140029
SupplementS024
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
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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