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City Mountain View / / Company Remote Monitor Application Software / NeuroPace Inc. / EMC / / Country United States / / Currency pence / / Event FDA Phase / / Facility Laboratory Studies / / IndustryTerm secure web browser / software verification testing / wireless radio testing / surgical tools / home-use monitoring device / treatment of epilepsy / imaging / data using telephone lines / Software development / implantable device / therapy for epilepsy / target site / product software requirement specification / electrical energy / therapeutic ultrasound diathermy device / Wireless co-existence testing / near metal detectors / / MedicalCondition patient experiences clinical seizures / Allergic reaction / lymphoma / headache / seizures / severe injury / coma / balance disorder / complex partial seizures / resective epilepsy / Mechanical shock / tonic-clonic seizures / influenza / partial onset seizures / head injury / upper respiratory tract infection / pain of skin / site infection / abdominal pain / nasopharyngitis / clinical epileptic seizures / Thermal shock / implanted material Lead migration Stroke Brain abscess / seizure / vomiting / epileptic seizure / epilepsy / Irritation / depression / pharyngitis / Flexural fatigue / status epilepticus / / MedicalTreatment neurosurgery / surgery / Electroconvulsive Therapy / radiation / electrical stimulation of the brain / adjunctive therapy / Diathermy / drug therapy / / Organization U.S. Securities and Exchange Commission / Federal Communications Commission / United Nations / FDA / / Person Wand / Unsafe / / Position physician / General / Programmer Application Software model 3302 / model / General Information Device Generic Name / Programmer / / Product DTR-300 Remote Monitor / P-01 / F-01 / Use The RNS® System / / ProvinceOrState California / / TVStation Wand / / Technology radiation / X-ray / ultrasound / microwave / mobile phones / Integrated Circuits / MRI / cellular telephone / dielectric / neurosurgery / radio frequency / / URL www.neuropace.com / /
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NeuroPace® RNS® System PMA P100026 Summary of Safety and Effectiveness Data ____________________________________________________________________