FDA Product Code PAH: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.
Leading manufacturers include Coloplast A/S and Coloplast Corp..
FDA 510(k) Cleared Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling Devices (Product Code PAH)
About Product Code PAH - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code PAH since 2002, with 20 receiving FDA clearance (average review time: 132 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under PAH have taken an average of 59 days to reach a decision - down from 135 days historically, suggesting improved FDA processing for this classification.
PAH devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →