PAI · Class III · 21 CFR 884.5980

FDA Product Code PAI: Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

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.

Leading manufacturers include Tissue Science Laboratories, Plc and Cook Biotech Incorporated.

2
Total
2
Cleared
58d
Avg days
2005
Since

FDA 510(k) Cleared Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed Devices (Product Code PAI)

2 devices
1–2 of 2
Cleared Apr 05, 2013
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
K130006
Cook Biotech Incorporated
Obstetrics & Gynecology · 93d
Cleared Mar 09, 2005
PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150
K050355
Tissue Science Laboratories, Plc
Obstetrics & Gynecology · 23d

About Product Code PAI - Regulatory Context