RHA 2, RHA 3, RHA 4
FDA premarket approval P170002 · decided 2017-10-19
Approval details
- PMA number
- P170002
- Trade name
- RHA 2, RHA 3, RHA 4
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Teoxane S.A.
- Date received
- 2017-01-17
- Decision date
- 2017-10-19
- Days to decision
- 275 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Geneva
- 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 superficia
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