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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 GEL IMPLANTS
Classification Nameimplant, dermal, for aesthetic use
Generic Namejuvederm gel implants
ApplicantALLERGAN
PMA NumberP050047
Supplement NumberS018
Date Received07/22/2011
Decision Date01/20/2012
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to add additional testing on two raw materials used in the manufacture of the device which included additional testing of raw materials.
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