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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®3 dermal filler
Generic NameImplant, dermal, for aesthetic use
ApplicantTEOXANE S.A.
Les Charmilles
Rue de Lyon 105
Geneva 1203
PMA NumberP170002
Supplement NumberS030
Date Received05/01/2023
Decision Date10/27/2023
Product Code LMH 
Docket Number 23M-5342
Notice Date 12/08/2023
Advisory Committee General & Plastic Surgery
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for RHA®3 for expanding the indications to include injection in the vermillion body, vermillion border and oral commissures to achieve lip augmentation and lip fullness in adults aged 22 years or older. RHA®3 is also indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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