FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Barrier, Absorbable, Adhesion
PMA: P240015
·
Decision Sep 9, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Barrier, Absorbable, Adhesion
- Trade Name
- Womed Leaf Resorbable Adhesion Barrier
- PMA Number
- P240015
- Device Class
- FDA Class 3
- Product Code
- MCN
- Generic Name
- Barrier, absorbable, adhesion
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 9, 2025
- Date Received
- May 10, 2024
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCN | Barrier, Absorbable, Adhesion | FDA class 3 | Unknown |