PAH

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Product code
PAH
Device name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Device class
Class 2
21 CFR
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
20 (all years; only the last 3 years are listed here)

FDA classification definition

Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-10-18.

NumberDecision dateApplicantDevice nameSummary
K2424732024-10-18Coloplast Corp.Altis Single Incision Sling System (519650); Aris Tr…PDF

1 summaries are archived here for direct download.

Official FDA classification page: PAH
Classification and pathway per current FDA publications. Data from openFDA (CC0).