Evolysse® FORM
FDA premarket approval P240022/S003 · decided 2025-12-18
Approval details
- PMA number
- P240022
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Evolysse® FORM
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Symatese
- Date received
- 2025-11-21
- Decision date
- 2025-12-18
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Chaponost
- Statement
- Approval for changes to the Informed Consent Form used in the Post-Approval Study.
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