GZA — Implanted Cerebellar Stimulator Class III

FDA Device Classification

FDA product code GZA covers "Implanted Cerebellar Stimulator", a Class III medical device regulated under 21 CFR 882.5820. Submissions are reviewed by the Neurology panel. Devices under this code are implants.

Classification Details

Product Code
GZA
Device Class
Class III
Regulation Number
882.5820
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
Yes

Definition

Call for pmas 9/26/84 per 49 fr 26574 on 6/28/84