PMA P240015
- Device
- Womed Leaf
- Applicant
- Womed Sas
- Product code
- MCN
- Decision date
- 2026-01-28
- Generic name
- Barrier, absorbable, adhesion
- Approval order 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
Current openFDA PMA Record#
- Device
- Womed Leaf
- Applicant
- Womed Sas
- PMA number
- P240015
- Supplement
- S001
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2026-01-28
- Decision code
- OK30
- Date received
- 2025-12-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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