PAI — Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed Class III

FDA Device Classification

Classification Details

Product Code: PAI
Device Class: Class III
Regulation Number: 884.5980
Submission Type
Review Panel: OB
Medical Specialty: Obstetrics/Gynecology
Implant: Yes

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K130006	cook biotech incorporated	BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS	April 5, 2013
K050355	tissue science laboratories	PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MO	March 9, 2005