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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 NumberS015
Date Received03/29/2021
Decision Date04/26/2021
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  
Change to the location of temperature sensors and biological indicators during the sterilization process qualification.
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