Premarket Approval (PMA)

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.

• Device: Restylane Refyne, Restylane Defyne
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Q-Med AB; Seminariegatan 21; Uppsala S-752-7522
• PMA Number: P140029
• Date Received: 12/11/2014
• Decision Date: 12/09/2016
• Product Code: LMH
• Docket Number: 16M-4344
• Notice Date: 12/14/2016
• Advisory Committee: General & Plastic Surgery
• Clinical Trials: NCT01205048
• Expedited Review Granted?: No
• Combination Product: Yes

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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Supplements: S001 S003 S004 S006 S007 S008 S009 S010 S011 S012 S013 ; S014 S015 S016 S017 S019 S020 S021 S022 S023 S024 S025 S026 ; S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 ; S040 S042 S043 S044 S045 S046 S047 S048 S049 S050