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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplant, dermal, for aesthetic use
Generic Namejuvederm gel implants
PMA NumberP050047
Supplement NumberS050
Date Received08/31/2015
Decision Date09/30/2015
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
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.