GZE — Implanted Diaphragmatic/Phrenic Nerve Stimulator Class III
FDA product code GZE covers "Implanted Diaphragmatic/Phrenic Nerve Stimulator", a Class III medical device regulated under 21 CFR 882.5830. Submissions are reviewed by the Neurology panel. Devices under this code are implants.
Classification Details
- Product Code
- GZE
- Device Class
- Class III
- Regulation Number
- 882.5830
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Neurology
- Implant
- Yes
Definition
Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86