PMA P100026S047

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S047
Product code: PFN
Decision date: 2017-08-14
Classification: Implanted Brain Stimulator For Epilepsy
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Approval for the Neurostimulator (model RNS-320), NeuroPace Programmer (model 5000), Patient Data Management System (PDMS, model 4340), and Remote Monitor (model 5100).

Current openFDA PMA Record#

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S047
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2017-08-14
Decision code: APPR
Date received: 2017-02-15
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Neurostimulator (model RNS-320), NeuroPace Programmer (model 5000), Patient Data Management System (PDMS, model 4340), and Remote Monitor (model 5100).