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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.
 
Trade NameJUVEDERM HYALURONATE
Classification Nameimplant, dermal, for aesthetic use
Generic Namejuvederm gel implants
ApplicantALLERGAN
PMA NumberP050047
Supplement NumberS022
Date Received01/25/2012
Decision Date02/24/2012
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the addition of a new precaution statement: failure to comply with these instructions could result in needle disengagement and/or product leakage at te luer-lock needle hub connection.
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