PMA P100026S051

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S051
Product code: PFN
Decision date: 2018-01-09
Classification: Implanted Brain Stimulator For Epilepsy
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Two changes to occur at NeuroPaces approved battery supplier: 1) to replace an aging Lid Assembly Machine (LAM) welding equipment with equivalent equipment; and 2) to change the sourcing location of the battery ferrules (same supplier, different location).

Current openFDA PMA Record#

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S051
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2018-01-09
Decision code: OK30
Date received: 2017-12-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Two changes to occur at NeuroPaces approved battery supplier: 1) to replace an aging Lid Assembly Machine (LAM) welding equipment with equivalent equipment; and 2) to change the sourcing location of the battery ferrules (same supplier, different location).