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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, RHA® Redensity Mepi
Generic NameImplant, dermal, for aesthetic use
ApplicantTeoxane S.A.
Les Charmilles Rue De Lyon, 105
Geneva 1203
PMA NumberP170002
Supplement NumberS045
Date Received09/18/2024
Decision Date10/18/2024
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P170002/S034.
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