PMA P240015
- Device
- Womed Leaf
- Applicant
- Womed Sas
- Product code
- MCN
- Decision date
- 2026-08-31
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- approval for changes to the manufacturing process and materials used to manufacture the plunger component of the inserter
Current openFDA PMA Record#
- Device
- Womed Leaf
- Applicant
- Womed Sas
- PMA number
- P240015
- Supplement
- S002
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2026-08-31
- Decision code
- APPR
- Date received
- 2026-06-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for changes to the manufacturing process and materials used to manufacture the plunger component of the inserter