|
Device | NeuroPace RNS System |
Generic Name | Implanted brain stimulator for epilepsy |
Applicant | NEUROPACE INC 455 N. BERNARDO AVE MOUNTAIN VIEW, CA 94043 |
PMA Number | P100026 |
Supplement Number | S079 |
Date Received | 03/17/2020 |
Decision Date | 03/20/2020 |
Product Code |
PFN |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Modify the Telemetry Only System (TOS) and PXI Vader Temperature Test System Automatic Test Equipment (ATE) databases to improve yield of the components usedto manufacture the RNS® Neurostimulator (model RNS-320). |