Resorbable mesh for soft tissue deficiencies
Notified Body #
- 2797
Internal CECP dossier #
Date of reception of the dossier
- 01.08.2022
Field of expert panel
- General and plastic surgery,
- Dentistry
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
- class III implantable
Screening step:
appropriate medical field
/ competence area
- General and plastic surgery,
- Dentistry
Novelty of device
and/or of related clinical procedure
- No novelty