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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
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
Allergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP110033
Supplement NumberS019
Date Received08/31/2015
Decision Date09/30/2015
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typespecial (immediate track)
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR REVISED LABELING TO INCLUDE FDA¿S SUGGESTED VERBIAGE, VERBATIM, TO ENHANCE THE INFORMATION PROVIDED TO PATIENTS AND PHYSICIANS ABOUT THE RISKS ASSOCIATED WITH VASCULAR INJECTION.
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