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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 NumberS031
Date Received08/03/2013
Decision Date11/26/2013
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for change to the concentration of the lidocaine solution introduced to the gel during the homogenization step from 50% w/w to 30% w/v lidocaine hydrochloride and a revalidation, by weight, the amount of gel that can be mixed during the homogenization step of the manufacturing process.
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