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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
ApplicantAllergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP110033
Supplement NumberS025
Date Received12/23/2016
Decision Date01/17/2017
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 cleaning procedure of mixing and transfer vessels used during the manufacturing of Juvederm injectable gel products.
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