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
• Predetermined Change Control Plan Authorized: No

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: S019 S020 S023 S017 S010 S008 S009 S026 S027 S028 S029 ; S032 S033 S039 S044 S045 S046 S035 S036 S037 S038 S006 S002 ; S003 S004 S007 S005 S013 S024 S030 S031 S018 S014 S015 S016 ; S021 S022 S012 S025 S042 S043 S047 S049 S034 S040