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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 2, RHA 3, RHA 4 dermal fillers
Generic NameImplant, dermal, for aesthetic use
ApplicantTeoxane S.A.
Les Charmilles Rue De Lyon, 105
Geneva 1203
PMA NumberP170002
Supplement NumberS014
Date Received03/16/2021
Decision Date04/15/2021
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate 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 updated labeling to include adverse events from post market surveillance for RHA 2, RHA 3, and RHA 4
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