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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 IMPKANTS
Classification Nameimplant, dermal, for aesthetic use
Generic Namejuvederm gel implants
ApplicantALLERGAN
PMA NumberP050047
Supplement NumberS019
Date Received08/01/2011
Decision Date09/23/2011
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an extension of the shelf life from 12 months to 24 months for the 0. 8ml syringe (0. 4ml and 0. 8ml volumes); an increase in the monoethylglycinexyidide (megx) impurity specification from <= 0. 3% w/w of label strength to <= 2. 0% w/w of label strength; and an increase in total impurities specification from <= 0. 5% w/w of label strength to <= 2. 5% w/w of label strength.
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