Product code OTM
- Device name
- Mesh, Surgical, For Stress Urinary Incontinence, Male
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- surgical treatment of male stress urinary incontinence post-prostatectomy
- Source
- FDA openFDA device classification dataset