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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceRHA® Redensity™
Generic NameImplant, dermal, for aesthetic use
ApplicantTEOXANE S.A.
Les Charmilles
Rue de Lyon 105
Geneva 1203
PMA NumberP170002
Supplement NumberS012
Date Received01/08/2021
Decision Date12/22/2021
Product Code LMH 
Docket Number 22M-0071
Notice Date 01/04/2022
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT03092219
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the RHA® Redensity is indicated for injection into the dermis and superficial dermis of the face, for the correction of moderate to severe dynamic perioral rhytids, in adults aged 22 years or older.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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