PMA P100026S060

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S060
Product code: PFN
Decision date: 2018-10-05
Classification: Implanted Brain Stimulator For Epilepsy
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: NeuroPace's battery supplier, Integer, to use an alternate supplier (second tier) to procure electrolyte used in batteries for RNS Neurostimulator model RNS-300M and model RNS-320.

Current openFDA PMA Record#

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S060
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2018-10-05
Decision code: OK30
Date received: 2018-10-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: NeuroPace's battery supplier, Integer, to use an alternate supplier (second tier) to procure electrolyte used in batteries for RNS Neurostimulator model RNS-300M and model RNS-320.