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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 Ultra, Ultra XC, Ultra Plus, Ultra Plus XC, 30; Juvedern Ultra XC
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
2525 dupont dr.
irvine, CA 92612
PMA NumberP050047
Supplement NumberS054
Date Received11/21/2016
Decision Date12/16/2016
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Implementation of additional manufacturing capabilities within the existing syringe assembly and packaging line.