Premarket Approval (PMA)

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.

• Device: JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: Allergan; 2525 Dupont Dr.; Irvine, CA 92612
• PMA Number: P050047
• Date Received: 12/05/2005
• Decision Date: 06/02/2006
• Product Code: LMH
• Docket Number: 06M-0235
• Notice Date: 06/29/2006
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: 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: S017 S018 S014 S015 S016 S019 S030 S050 S020 S005 S003 ; S002 S054 S073 S057 S058 S006 S007 S009 S012 S013 S010 S011 ; S052 S053 S059 S060 S055 S056 S063 S068 S071 S075 S076 S086 ; S083 S089 S095 S102 S103 S104 S105 S096 S093 S061 S062 S064 ; S065 S069 S070 S072 S094 S090 S091 S099 S100 S101 S001 S028 ; S046 S038 S039 S040 S041 S025 S042 S043 S033 S021 S022 S027 ; S034 S035 S023 S051 S008 S047 S048 S077 S037 S044 S045 S078 ; S079 S074 S066 S067 S081 S082 S032 S024 S080 S036 S085 S031 ; S087 S088 S092 S097