|
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 | S072 |
Date Received | 06/20/2019 |
Decision Date | 06/24/2019 |
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 Change the glass weave used to produce the inner core in the fabrication of the printed circuit board (PCB) of the RNS Neurostimulator (Model RNS-320). |