Food and Drug Administration Materials
Object Details
- Collection Creator
- Think Surgical, Inc. (Fremont, California)
- See more items in
- Records of Think Surgical, Inc.
- Date
- 1987 - 2001
- Archival Repository
- Archives Center, National Museum of American History
- Identifier
- NMAH.AC.1378, Series 4
- Type
- Archival materials
- Collection Rights
- Collection items available for reproduction, but the Archives Center makes no guarantees concerning copyright restrictions. Other intellectual property rights may apply. Archives Center cost-recovery and use fees may apply when requesting reproductions.
- Scope and Contents
- This series consists of materials related to Food and Drug Administration (FDA) approval of Robodocâ„¢ 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.
- Collection Restrictions
- Collection is open for research.
- Record ID
- ebl-1503510335798-1503510335813-5
- Metadata Usage
- CC0