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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 NumberS020
Date Received01/31/2022
Decision Date02/24/2022
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  
Removal of in-process control (IPC) tests for pH at dialysis and rheology at filling during the manufacturing of RHA 2, RHA 3, and RHA 4
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