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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 Mepi
Generic NameImplant, dermal, for aesthetic use
ApplicantTeoxane S.A.
Les Charmilles Rue De Lyon, 105
Geneva 1203
PMA NumberP170002
Supplement NumberS043
Date Received08/07/2024
Decision Date01/17/2025
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT04540913
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for expanding the labeling of RHA® 3 Mepi to add a new indication for injection in the vermillion body, vermillion border and oral commissures to achieve lip augmentation and lip fullness in subjects aged 22 or older.
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