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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
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP110033
Supplement NumberS013
Date Received02/24/2015
Decision Date03/26/2015
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
EXPANSION OF THE PRINGY II MANUFACTURING FACILITY AND ASSOCIATED MINOR CHANGES TO THE UTILITIES DISTRIBUTION SYSTEM AT THE FACILITY, TO ACCOMMODATE THE ADDEDMANUFACTURING SPACE.
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