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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
Generic NameImplant, dermal, for aesthetic use
ApplicantTEOXANE S.A.
Les Charmilles
Rue de Lyon 105
Geneva 1203
PMA NumberP170002
Supplement NumberS013
Date Received02/17/2021
Decision Date03/19/2021
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Declare the change of analytical laboratory in charge of the assay of sodium hyaluronate (NaHA) content in the finished products at the release step for RHA2, RHA3, and RHA4.
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