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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, and RHA 4 Dermal Fillers
Generic NameImplant, dermal, for aesthetic use
ApplicantTeoxane S.A.
Les Charmilles Rue De Lyon, 105
Geneva 1203
PMA NumberP170002
Supplement NumberS005
Date Received06/18/2019
Decision Date10/29/2019
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for extension of products’ shelf-life from 17 months to 36 months.
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