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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
Generic NameComputer-assisted personalized sedation system
ApplicantScott Laboratories, Inc.
2804 N. Loop 289
Lubbock, TX 79415
PMA NumberP080009
Date Received03/25/2008
Decision Date05/03/2013
Withdrawal Date03/17/2025
Product Code PDR 
Docket Number 13M-0549
Notice Date 05/08/2013
Advisory Committee Anesthesiology
Clinical TrialsNCT00452426
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S007 S008 S009 S010 S011 S012 
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