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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.
 
DeviceJUVEDERM HYALURONATE GEL IMPLANTS
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
Allergan
2525 dupont dr.
irvine, CA 92612
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 - indications/instructions/shelf life/tradename
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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