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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 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
Allergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP050047
Supplement NumberS052
Date Received04/04/2016
Decision Date04/29/2016
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the Directions for Use and Patient Labeling including updated postmarket surveillance data as well as other changes to harmonize pertinent content across Juvederm labeling documents. Minor typographical revisions and clarifications are also included.
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