Device Dossier
Uterus-supporting pessary
Device Dossier for Uterus-supporting pessary (Uterus-supporting pessary, Class IIa, sponsor Sigma Company). ARTG record, intended purpose, GMDN category…
- GMDN category: Uterus-supporting pessary
- Sponsor: Sigma Company
Intended purpose
This is a device that is intended to be inserted into the vagina. This device is intended to be used for mild prolapse as well as urinary incontinence also for mild first-degree prolapse and used for an accompanying cystocele. The device is also intended to be used for second- to third-degree prolapse or procidentia, a rectocele as well as being effective in the prevention of exercise incontinence in women.