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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameJUVEDERM VOLUMA XC
Classification Nameimplant, dermal, for aesthetic use
ApplicantALLERGAN
PMA NumberP110033
Supplement NumberS001
Date Received11/06/2013
Decision Date12/06/2013
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Proposed addition of new sterilization equipment for use in juvederm voluma xc sterilization.
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