Food and Drug Administration Materials
name: label: Collection Creator
content: Think Surgical, Inc. (Fremont, California)
setName: label: See more items in
content: Records of Think Surgical, Inc.
unitdate: label: Date
content: 1987 - 2001
dataSource: label: Archival Repository
content: Archives Center, National Museum of American History
identifier: label: Identifier
content: NMAH.AC.1378, Series 4
objectType: label: Type
content: Archival materials
scopecontent: label: Scope and Contents
content: This series consists of materials related to Food and Drug Administration (FDA) approval of Robodoc™ Surgical Assistant System. The materials include primarily correspondence, clinical trial data and agreements, notes, articles, study protocols, patient consent forms, clinical study case report forms and other materials created for institutional review committees.  Many of the clinical trial documents provide condensed information about the device (Robodoc) protocols used, risk analysis, monitoring procedures, and consent forms. Also included is correspondence with Advanced Biosearch Associates (ABA), a contract Food and Drug Administration (FDA) regulatory and clinical research firm. ABA was founded in 1979 and is based in Danville, California.