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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceJUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
Allergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP050047
Date Received12/05/2005
Decision Date06/02/2006
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 06M-0235
Notice Date 06/29/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the juvederm 24hv, juvederm 30 and juvederm 30hv gel implants. The device 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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S027 S028 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S046 S047 S048 
S050 S051 S052 S053 
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