PAJ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Device class

Class II (moderate risk)

Regulation

21 CFR 878.3300

Medical specialty

General, Plastic Surgery

Flags

Implant

FDA definition

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

Adverse events (MAUDE)

2013: 61 · 2014: 66 · 2015: 286 · 2016: 267 · 2017: 96
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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