GZE

Implanted Diaphragmatic/Phrenic Nerve Stimulator

Product code
GZE
Device name
Implanted Diaphragmatic/Phrenic Nerve Stimulator
Device class
Class 3
21 CFR
21 CFR 882.5830
Medical specialty
Neurology
Marketing pathway
PMA
Flag
Implant

FDA classification definition

Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: GZE
Classification and pathway per current FDA publications. Data from openFDA (CC0).