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: RHA 2, RHA 3, RHA 4
• Generic Name: Implant, dermal, for aesthetic use
• Applicant: TEOXANE S.A.; Les Charmilles; Rue de Lyon 105; Geneva 1203
• PMA Number: P170002
• Date Received: 01/17/2017
• Decision Date: 10/19/2017
• Product Code: LMH
• Docket Number: 17M-6232
• Notice Date: 10/23/2017
• Advisory Committee: General & Plastic Surgery
• Clinical Trials: NCT02195427
• 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: S034 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 ; S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 ; S025 S026 S027 S028 S029 S030 S031 S032 S033 S036 S038