PMA P100026S068

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S068
Product code: PFN
Decision date: 2019-05-24
Classification: Implanted Brain Stimulator For Epilepsy
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Addition of a new wafer sort test to the manufacturing flow of the RNS® Neurostimulator (model RNS-320). This testing service will be performed at a new supplier, NeuroPace’s approved supplier Integra Technologies (located at 1635 McCarthy Blvd, Milpitas, CA 95035).

Current openFDA PMA Record#

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S068
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2019-05-24
Decision code: OK30
Date received: 2019-05-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a new wafer sort test to the manufacturing flow of the RNS® Neurostimulator (model RNS-320). This testing service will be performed at a new supplier, NeuroPace’s approved supplier Integra Technologies (located at 1635 McCarthy Blvd, Milpitas, CA 95035).