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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 ULTRA XC AND JUVEDERM ULTRA PLUS XC
Classification Nameimplant, dermal, for aesthetic use
Generic Namejuvederm gel implants
ApplicantALLERGAN
PMA NumberP050047
Supplement NumberS005
Date Received08/18/2008
Decision Date01/07/2010
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Clinical Trials NCT00653861
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for the addition of 0. 3% lidocaine into juvederm ultra and juvederm ultra plus. The device, as modified, will be marketed under the trade name juvederm ultra xc and juvederm ultra plus xc and is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
Approval Order Approval Order
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