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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.
DeviceJuvéderm Ultra, Ultra XC, Ultra, Juvéderm Ultra XC
Generic NameImplant, dermal, for aesthetic use
IRVINE, CA 92612
PMA NumberP050047
Supplement NumberS058
Date Received03/20/2017
Decision Date08/25/2017
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 an additional syringe assembly and packaging line.