• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
Trade NameSEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
Classification Namecomputer-assisted personalized sedation system
ApplicantETHICON ENDO-SURGERY, INC.
PMA NumberP080009
Date Received03/25/2008
Decision Date05/03/2013
Product Code
PDR[ Registered Establishments with PDR ]
Docket Number 13M-0549
Notice Date 05/08/2013
Advisory Committee Anesthesiology
Clinical Trials NCT00452426
Expedited Review Granted? Yes
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the sedasys® computer-assisted personalized sedation system. This device is indicated for the intravenous administration of 1% (10 mg/ml) propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation, as defined by the american society of anesthesiologists (asa) continuum of depth of sedation, in asa physical status i and ii patients >= 18 years old undergoing colonoscopy and esophagogastroduod-denoscopy (egd) procedures.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
-
-