DeviceClearance

Product code PAH— General, Plastic Surgery

AMS MINIARC SLING SYSTEM

Classification name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
20
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PAH under 21 CFR 878.3300, via openFDA

Market context for product code PAH

FDA has cleared 20 devices under product code PAH between 2002 and 2024, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PAH

Adverse events under product code PAH

product code PAH
Injury
886
Malfunction
529
Total
1,415

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PAH

Data sourced from openFDA. This site is unofficial and independent of the FDA.