EVOLYSSE SMOOTH and EVOLYSSE FORM
FDA premarket approval P240022 · decided 2025-02-13
Approval details
- PMA number
- P240022
- Trade name
- EVOLYSSE SMOOTH and EVOLYSSE FORM
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Symatese
- Date received
- 2024-06-21
- Decision date
- 2025-02-13
- Days to decision
- 237 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Chaponost
- Statement
- Dermal and subdermal injection to correct moderate to severe dynamic facial wrinkles and folds (such as NLFs) in adults 22 years or older.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.