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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 NumberS018
Date Received08/03/2015
Decision Date05/31/2016
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 16M-1401
Notice Date 06/02/2016
Advisory Committee General & Plastic Surgery
Clinical Trials NCT01998581
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for JUVÉDERM VOLBELLA® XC injectable gel. The device is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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