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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.
 
DeviceRHA 2, RHA 3, RHA 4
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
TEOXANE S.A.
rue de lyon 105
geneva 1203
PMA NumberP170002
Date Received01/17/2017
Decision Date10/19/2017
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 17M-6232
Notice Date 10/23/2017
Advisory Committee General & Plastic Surgery
Clinical Trials NCT02195427
NCT02253147
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the RH-2. The RHA 2 is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older. RHA 3 is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older. RHA 4 is indicated for injection into the deep dermis to superficial subcutaneous tissue for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S002 S003 
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