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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecomputer-assisted personalized sedation system
Generic Namecomputer-assisted personalized sedation system
4545 creek rd.
mail location 110
cincinnati, OH 45242-2839
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 No
Recalls CDRH Recalls
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 andmaintenance 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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 S012