Resorbable mesh for soft tissue deficiencies

Notified Body #

Internal CECP dossier #

Date of reception of the dossier

Field of expert panel

Medical device type

[…] is a fully resorbable mesh with a resorbable hydrogel coating. It is a sterile mesh device designed for the reinforcement and reconstruction of soft tissue deficiencies, co-knitted using poly-4-hydroxybutyrate (P4HB, < 60%) and polyglycolic acid (PGA, <15%) fibers.

Intended purpose

The device is indicated for use in the reinforcement of abdominal soft tissue, where weakness exists, in ventral and hiatal hernia repair procedures.

Risk class / type

Screening step:
appropriate medical field
/ competence area

Novelty of device
and/or of related clinical procedure