DeviceClearance

Product code PAJ— General, Plastic Surgery

BVI SLING

Classification name
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PAJ under 21 CFR 878.3300, via openFDA

Market context for product code PAJ

FDA has cleared 2 devices under product code PAJ between 2000 and 2005, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PAJ

Recent clearances under product code PAJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.