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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 VOLBELLA XC
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
Allergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP110033
Supplement NumberS023
Date Received06/14/2016
Decision Date09/01/2016
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the addition of a 0.55 mL-filled syringe configuration in the same 1 mL COC syringe for Juvederm VOLBELLA XC.
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