• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceJUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP050047
Date Received12/05/2005
Decision Date06/02/2006
Product Code LMH 
Docket Number 06M-0235
Notice Date 06/29/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S034 S024  S008 S047 S048 S023 S053 S035 S025 S027 S014 
S015 S016 S017 S018 S019 S020 S086 S082 S083 S087 S088 S080 
S090 S091 S051 S044 S045 S033 S037 S038 S006 S007 S001 S055 
S032 S030 S046 S028 S039 S040 S041 S021 S022 S042 S043 S050 
S031 S036 S005 S009 S012 S013 S003 S002 S010 S011 S052 S056 
S057 S058 S054 S059 S060 S062 S071 S069 S070 S073 S068 S077 
S081 S085 S092 S089 S063 S064 S065 S061 S074 S066 S067 S075 
S076 S078 S079 S072 S093 
-
-