PMA P100026S089

Device: NeuroPace® RNS® System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S089
Product code: PFN
Decision date: 2021-12-16
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Add an existing NeuroPace supplier as an alternate supplier to manufacture the PEEK Connector Cover part of the Connector Cover Assemblies and Connector Cover Kits for the RNS Neurostimulators (Model RNS-320 and RNS-300M) and to manufacture this part by injection molding rather than by the current machining process.

Current openFDA PMA Record#

Device: NeuroPace® RNS® System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S089
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2021-12-16
Decision code: OK30
Date received: 2021-11-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add an existing NeuroPace supplier as an alternate supplier to manufacture the PEEK Connector Cover part of the Connector Cover Assemblies and Connector Cover Kits for the RNS Neurostimulators (Model RNS-320 and RNS-300M) and to manufacture this part by injection molding rather than by the current machining process.