PMA P100026S079

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S079
Product code: PFN
Decision date: 2020-03-20
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Modify the Telemetry Only System (TOS) and PXI Vader Temperature Test System Automatic Test Equipment (ATE) databases to improve yield of the components usedto manufacture the RNS® Neurostimulator (model RNS-320).

Current openFDA PMA Record#

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S079
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2020-03-20
Decision code: OK30
Date received: 2020-03-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modify the Telemetry Only System (TOS) and PXI Vader Temperature Test System Automatic Test Equipment (ATE) databases to improve yield of the components usedto manufacture the RNS® Neurostimulator (model RNS-320).