IDE Materials
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)