PAJ · Class II · 21 CFR 878.3300

FDA Product Code PAJ: Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Bridging Material To Attach The Vaginal Apex Or Uterus To The Sacral Promontory; Procedures Include Abdominal Sacrocolpopexy, Laparoscopic Sacrocolpopexy And Robot-assisted Sacrocolpopexy.

Leading manufacturers include Bio-Vascular, Inc. and Tei Biosciences, Inc..

2
Total
2
Cleared
56d
Avg days
2000
Since

FDA 510(k) Cleared Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed Devices (Product Code PAJ)

2 devices
1–2 of 2
Cleared Jun 10, 2005
XENFORM SOFT TISSUE REPAIR MATRIX
K051190
Tei Biosciences, Inc.
Obstetrics & Gynecology · 31d
Cleared Oct 13, 2000
BVI SLING
K002233
Bio-Vascular, Inc.
Obstetrics & Gynecology · 81d

About Product Code PAJ - Regulatory Context