DeviceClearance

Product code PAI— Obstetrics/Gynecology

BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS

Classification name
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device class
Class 3
Regulation
21 CFR 884.5980
Advisory panel
Obstetrics/Gynecology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical and uterine prolapse repair completed transvaginally.”

— U.S. Food and Drug Administration, device classification record for product code PAI under 21 CFR 884.5980, via openFDA

Market context for product code PAI

FDA has cleared 2 devices under product code PAI between 2005 and 2013, filed by 2 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

Clearances per year

Top applicants under product code PAI

Recent clearances under product code PAI

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