Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceRestylane Refyne, Restylane Defyne
Generic NameImplant, dermal, for aesthetic use
ApplicantQ-Med AB
Seminariegatan 21
Uppsala S-752-7522
PMA NumberP140029
Date Received12/11/2014
Decision Date12/09/2016
Product Code LMH 
Docket Number 16M-4344
Notice Date 12/14/2016
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT01205048
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for Restylane Refyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21. Restylane Defyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe, deep facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S003 S004 S017 S020 S021 S025 S029 S030 S031 S037 
S038 S049 S042 S043 S044 S050 S008 S009 S010 S011 S012 S006 
S007 S013 S014 S026 S027 S016 S022 S023 S032 S033 S034 S024 
S019 S015 S028 S040 S048 S035 S036 S047 S045 S046