PLJ — Tissue Adhesive Internal Use Class III

FDA Device Classification

FDA product code PLJ covers "Tissue Adhesive Internal Use", a Class III medical device regulated under 21 CFR 878.4010. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants.

Classification Details

Product Code
PLJ
Device Class
Class III
Regulation Number
878.4010
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Definition

Intended for the fixation of surgical meshes.