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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.
DeviceJuvederm Voluma® XC and Juvederm Volbella® XC
Generic NameImplant, dermal, for aesthetic use
IRVINE, CA 92612
PMA NumberP110033
Supplement NumberS026
Date Received02/09/2017
Decision Date05/12/2017
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for a change in the cleaning procedure for some equipment used in the manufacturing of injectable gel products