PAJ — Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed Class II

FDA Device Classification

Classification Details

Product Code
PAJ
Device Class
Class II
Regulation Number
878.3300
Submission Type
Review Panel
OB
Medical Specialty
General, Plastic Surgery
Implant
Yes

Definition

Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K051190tei biosciencesXENFORM SOFT TISSUE REPAIR MATRIXJune 10, 2005
K002233bio-vascularBVI SLINGOctober 13, 2000