Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
FDA product code PAH · 20 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.3300
- Review panel
- GU
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2002-05-15 – 2024-10-18
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
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