Study: UCSF / Parkinson’s Disease / Medtronic Summit RC+S system

• IDE Application - Complete (Link)
• IDE Risk Analysis Sections (Link)
• IDE Consent Document (Link)
• FDA Correspondence - Written IDE Presub Feedback (Link)
• IDE Presub Meeting Minutes (Link)

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Study: Baylor / OCD / Boston Scientific Vercise system

• FDA Correspondence - Acceptance of proposed changes to study protocol (Link)

Study: UCSF / Parkinson’s Disease - Subgaleal recordings / Medtronic Percept PC

• IDE Application - Complete (Link)

Study: Mayo Clinic / Epilepsy / Medtronic Summit RC+S system

• IDE Study Protocol (Link)
• FDA Correspondence - IDE review, sponsor response request (Link)
• FDA Correspondence - Written feedback to IDE Presub Questions (Link)
• FDA Presub Meeting Minutes (Link)
• DSMB Charter (Link)
• IDE Presub Packet (Link)
• IDE Consent Document (Link)

Study: UCSF / Chronic Pain / Medtronic Activa PC+S system

• IDE Study Protocol (Link)
• IDE Application - Cover Letter & Table of Contents (Link)