PMA P100026S080

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S080
Product code: PFN
Decision date: 2020-04-06
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Implement minor manufacturing changes to the die attach process and transfer mold process used for fabricating the RNS Neurostimulator (model RNS-320) stackeddie ball grid array (SDBGA).

Current openFDA PMA Record#

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S080
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2020-04-06
Decision code: OK30
Date received: 2020-04-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement minor manufacturing changes to the die attach process and transfer mold process used for fabricating the RNS Neurostimulator (model RNS-320) stackeddie ball grid array (SDBGA).