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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceEVOLYSSE™ SMOOTH and EVOLYSSE™ FORM
Generic NameImplant, dermal, for aesthetic use
ApplicantSymatese
Zi Les Troques
Chaponost 69630
PMA NumberP240022
Date Received06/21/2024
Decision Date02/13/2025
Product Code LMH 
Docket Number 25M-0437
Notice Date 02/21/2025
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT05325411
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Dermal and subdermal injection to correct moderate to severe dynamic facial wrinkles and folds (such as NLFs) in adults 22 years or older.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 S004 S005 
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