federal_register: 2011-6520

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
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...  

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