PMA P100026S053

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S053
Product code: PFN
Decision date: 2018-02-20
Classification: Implanted Brain Stimulator For Epilepsy
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Modify the automated test equipment (ATE) test flow and PXI Vader ATE hardware, software as well as test database to support the manufacture of the RNS® Neurostimulator (model RNS-320).

Current openFDA PMA Record#

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S053
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2018-02-20
Decision code: OK30
Date received: 2018-01-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modify the automated test equipment (ATE) test flow and PXI Vader ATE hardware, software as well as test database to support the manufacture of the RNS® Neurostimulator (model RNS-320).