IDE Materials


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)

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)

  • IDE Presub Meeting Minutes & Agenda (Link)

  • IDE Sponsor Response to Reviewer Questions (Link)

Study: UCSF Chronic Pain / Medtronic Summit RC+S system

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

  • IDE Consent & Case Report Documents (Link)

  • IDE Presub Meeting Minutes & Agenda (Link)

  • IDE Presub Meeting Minutes & Agenda (Revisions) (Link)

  • IDE Adverse Event Form (Link)

  • IDE Adverse Event Form v2 (Link)

  • IDE Presub Inquiry - Proposed Additional Target (Link)

  • FDA Correspondence - Approval of IDE Supplement (additional target) (Link)

Study: UCSF / Chronic Pain / Medtronic Percept system

  • IDE Study Protocol (Link)

  • IDE Informed Consent Documents (Link)

  • IDE Summit RC+S vs Percept Comparison Table (Link)

Study: Emory / Major Depression / St. Jude Libra system (2006)

  • IDE Study Protocol (Link)

  • IDE Consent Document (Link)

  • IDE Main Application (no appendicies) (Link)

  • FDA Correspondence - Conditional approval of IDE application (Link)

  • FDA Correspondence - 2nd Conditional approval of IDE application (Link)