PMA P100026S056

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S056
Product code: PFN
Decision date: 2018-08-01
Classification: Implanted Brain Stimulator For Epilepsy
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Modify the PXI Vader automated test equipment (ATE) power-up software to improve yield of the components used to manufacture the RNS® Neurostimulator (model RNS-320) during the custom packaged integrated circuitry (Cassandra) and printed circuit assembly (PCA) testing. Additionally, the Dog Tag test limits for the integrated circuit are being modified in the PXI Vader ATE, Telemetry Only System (TOS) ATE and the PXI Vader Temperature ATE databases to allow flexibility to also test future integrated circuits for product development purposes.

Current openFDA PMA Record#

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S056
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2018-08-01
Decision code: OK30
Date received: 2018-07-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modify the PXI Vader automated test equipment (ATE) power-up software to improve yield of the components used to manufacture the RNS® Neurostimulator (model RNS-320) during the custom packaged integrated circuitry (Cassandra) and printed circuit assembly (PCA) testing. Additionally, the Dog Tag test limits for the integrated circuit are being modified in the PXI Vader ATE, Telemetry Only System (TOS) ATE and the PXI Vader Temperature ATE databases to allow flexibility to also test future integrated circuits for product development purposes.