{"database": "openregs", "table": "federal_register", "rows": [["2011-6520", "SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s, Petition for Review of FDA's Denial of Premarket Approval", "Notice", "The Food and Drug Administration (FDA) is announcing that it intends to refer for review before an advisory committee Ethicon Endo- Surgery Inc.'s (EES's), petition for review of the Agency's denial of premarket approval for its SEDASYS computer-assisted personalized sedation system (SEDASYS system).", "2011-03-21", 2011, 3, "https://www.federalregister.gov/documents/2011/03/21/2011-6520/sedasys-computer-assisted-personalized-sedation-system-ethicon-endo-surgery-incs-petition-for-review", "https://www.govinfo.gov/content/pkg/FR-2011-03-21/pdf/2011-6520.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is announcing that it intends to refer for review before an advisory committee Ethicon Endo- Surgery Inc.'s (EES's), petition for review of the Agency's denial of premarket approval for its SEDASYS...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2011-6520"], "units": {}, "query_ms": 120.89278607163578, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}