EZW — Stimulator, Electrical, Implantable, For Incontinence Class III

FDA Device Classification

FDA product code EZW covers "Stimulator, Electrical, Implantable, For Incontinence", 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
EZW
Device Class
Class III
Regulation Number
876.5270
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
Yes

Definition

PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))