FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Barrier, Absorbable, Adhesion
PMA: P240015
·
Supplement: S001
·
Decision Jan 28, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Barrier, Absorbable, Adhesion
- Trade Name
- Womed Leaf
- PMA Number
- P240015
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- MCN
- Generic Name
- Barrier, absorbable, adhesion
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- January 28, 2026
- Date Received
- December 29, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to add surface treatment and outsource the bonding process of the outer handle of the inserter and move to a semi-automated process for cutting and assembly
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 |