FDA.reportPublic FDA data

PMA P100026S078

Device
NeuroPace RNS System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S078
Product code
PFN
Decision date
2020-01-22
Generic name
Implanted brain stimulator for epilepsy
Approval order statement
Modify the PXI Vader automated test equipment (ATE) software, hardware, and test database to improve yield of the components used to manufacture the RNS® Neurostimulator (model RNS-320).

Current openFDA PMA Record#

Device
NeuroPace RNS System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S078
Product code
PFN
Generic name
Implanted brain stimulator for epilepsy
Decision date
2020-01-22
Decision code
OK30
Date received
2020-01-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modify the PXI Vader automated test equipment (ATE) software, hardware, and test database to improve yield of the components used to manufacture the RNS® Neurostimulator (model RNS-320).