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Womed Leaf Resorbable Adhesion Barrier

by Womed Sas

PMA P240015

Active European Union and United States

CE MDR PMA

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P240015↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP240015 Date9 Sep 2025ApprovedStatusActive
European UnionCE/MDR Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA PMA Active

Specification

PMA

Generic Name
Barrier, absorbable, adhesion
PMA Number
FDA Product Code
MCN
Device Class
Class III
Advisory Committee
Obstetrics/Gynecology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Womed Leaf Resorbable Adhesion Barrier is a barrier, absorbable, adhesion device 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. The device is designed to be used in obstetrics and gynecology settings. The Womed Leaf Resorbable Adhesion Barrier has received FDA PMA and MDR authorizations.

The device is supplied by Womed Sas and has a product code of MCN. It is classified as a class 3 device and has a generic name of Barrier, absorbable, adhesion. The Womed Leaf Resorbable Adhesion Barrier is intended for use in hysteroscopic surgery and is designed to be resorbable, reducing the need for additional surgical procedures to remove the device.

Other devices from Womed Sas

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Womed Leaf Resorbable Adhesion Barrier?

    The Womed Leaf Resorbable Adhesion Barrier is intended to reduce the reoccurrence and severity of post-surgical adhesion formation inside the uterus for adult women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions.

  • What authorizations has the Womed Leaf Resorbable Adhesion Barrier received?

    The Womed Leaf Resorbable Adhesion Barrier has received FDA PMA and MDR authorizations.

  • What is the product code of the Womed Leaf Resorbable Adhesion Barrier?

    The product code of the Womed Leaf Resorbable Adhesion Barrier is MCN.