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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.
 
DeviceREVANESSE ULTRA
Generic NameImplant, dermal, for aesthetic use
ApplicantPROLLENIUM MEDICAL TECHNOLOGIES INC.
138 INDUSTRIAL PARKWAY NORTH
AURORA L4G 4
PMA NumberP160042
Date Received09/22/2016
Decision Date08/04/2017
Product Code LMH 
Docket Number 17M-4711
Notice Date 08/07/2017
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT02984878
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Revanesse Ultra. The device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults 22 years of age or more.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S003 S004 S007 S009 S010 S011 S012 S013 S014 S015 
S016 S017 S018 S019 S020 S022 S023 S024 S025 S026 
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