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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
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP050047
Supplement NumberS065
Date Received04/05/2018
Decision Date05/04/2018
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  
Additional frame to be used during sterilization of Juvederm injectable gel implants.
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