PMA P100026S061

Device

NeuroPace RNS System

Applicant

NeuroPace, Inc.

PMA number

P100026

Supplement

S061

Product code

PFN

Decision date

2018-11-29

Classification

Implanted Brain Stimulator For Epilepsy

Generic name

Implanted brain stimulator for epilepsy

Approval order statement

Modify the Automatic Test Equipment (ATE) database and software to improve yield of components of the RNS® Neurostimulator (model RNS-320).

Summary

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