PMA P100026S042

Device: NEUROPACE RNS SYSTEM
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S042
Product code: PFN
Decision date: 2016-03-04
Classification: Implanted Brain Stimulator For Epilepsy
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Change to use a larger chamber for the ethylene oxide (EO) sterilization of RNS® System products at the same approved sterilization facility (Sterigenics, Salt Lake City, Utah).

Current openFDA PMA Record#

Device: NEUROPACE RNS SYSTEM
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S042
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2016-03-04
Decision code: OK30
Date received: 2016-02-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to use a larger chamber for the ethylene oxide (EO) sterilization of RNS® System products at the same approved sterilization facility (Sterigenics, Salt Lake City, Utah).