EZT — Pacemaker, Bladder Class III

FDA Device Classification

FDA product code EZT covers "Pacemaker, Bladder", a Class III medical device regulated under 21 CFR 876.5270. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants.

Classification Details

Product Code
EZT
Device Class
Class III
Regulation Number
876.5270
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
Yes

Definition

Call for PMAs 12/26/96 (61 FR 50707 (9/27/96))