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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/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.
 
DeviceRADIESSE INJECTABLE IMPLANT
Generic NameImplant, dermal, for aesthetic use
ApplicantMERZ NORTH AMERICA, INC
4133 COURTNEY ROAD
SUITE 10
FRANKSVILLE, WI 53126
PMA NumberP050052
Date Received12/22/2005
Decision Date12/22/2006
Product Code LMH 
Docket Number 07M-0007
Notice Date 01/17/2007
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR RADIESSE. THIS DEVICE IS INDICATED FOR SUBDERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S002 S003 S004 S005 S006 S007 S009 S010 S012 S013 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 
S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 
S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 
S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 S087 
S088 S089 S090 S091 S092 S093 S094 S095 S096 S097 S098 S099 
S100 S102 S104 S105 S106 S108 S109 S110 S111 S112 S113 S114 
S115 S116 S117 S118 S119 S120 S121 S122 S124 S125 S126 S127 
S128 S129 S130 S131 S132 S134 S135 S136 S137 S138 S139 S140 
S141 S142 S143 S144 S145 S146 S148 S149 S150 S152 S153 S154 
S155 S156 S157 
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