Womed Leaf Resorbable Adhesion Barrier
FDA premarket approval P240015 · decided 2025-09-09
Approval details
- PMA number
- P240015
- Trade name
- Womed Leaf Resorbable Adhesion Barrier
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Womed Sas
- Date received
- 2024-05-10
- Decision date
- 2025-09-09
- Days to decision
- 487 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Montpellier
- Statement
- Approval for the Womed Leaf® Resorbable Adhesion Barrier is intended to reduce the reoccurrence and severity of post-surgical adhesion formation inside the uterus. It is indicated for adult women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions.
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