PMA P240015

Device
Womed Leaf
Applicant
Womed Sas
Product code
MCN
Decision date
2026-10-25
Generic name
Barrier, absorbable, adhesion
Approval order statement
for labeling changes to reduce the chance of product expulsion

Current openFDA PMA Record#

Device
Womed Leaf
Applicant
Womed Sas
PMA number
P240015
Supplement
S003
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2026-10-25
Decision code
APPR
Date received
2026-07-29
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
for labeling changes to reduce the chance of product expulsion