PMA P100026S074

Device: NeuroPac RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S074
Product code: PFN
Decision date: 2019-08-26
Classification: Implanted Brain Stimulator For Epilepsy
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Addition of an alternate laser welder, the IPG Laser Weld System, to perform laser welding on the RNS Neurostimulator during manufacturing operations at NeuroPace (455 N. Bernardo Ave. Mountain, California).

Current openFDA PMA Record#

Device: NeuroPac RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S074
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2019-08-26
Decision code: OK30
Date received: 2019-08-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate laser welder, the IPG Laser Weld System, to perform laser welding on the RNS Neurostimulator during manufacturing operations at NeuroPace (455 N. Bernardo Ave. Mountain, California).