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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 NumberS020
Date Received09/26/2011
Decision Date01/20/2012
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an extension of the shelf life from 12 months to 18 months for the 1. 0ml syringe; an increase in the monoethylglycin-exylidide (megx) impurity specification from <=3% w/w of label strength to <=2. 5% w/w of label strength; and an increase in individual unidentified impurities specifications from <=0. 1% w/w of label strength to<=0. 2% w/w of label strength.
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