PMA P100026S073

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S073
Product code: PFN
Decision date: 2019-08-08
Classification: Implanted Brain Stimulator For Epilepsy
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Modify the PXI Vader automated test equipment (ATE) software to improve yield of the components used to manufacture the RNS® Neurostimulator (model RNS-320) during the custom packaged integrated circuit (Cassandra) and printed circuit assembly (PCA) testing. In addition, this submission includes an update to PXI Vader ATE software for final electrical test to support future product changes currently under development.

Current openFDA PMA Record#

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S073
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2019-08-08
Decision code: OK30
Date received: 2019-08-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modify the PXI Vader automated test equipment (ATE) software to improve yield of the components used to manufacture the RNS® Neurostimulator (model RNS-320) during the custom packaged integrated circuit (Cassandra) and printed circuit assembly (PCA) testing. In addition, this submission includes an update to PXI Vader ATE software for final electrical test to support future product changes currently under development.