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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
Classification Namecomputer-assisted personalized sedation system
Generic Namecomputer-assisted personalized sedation system
Applicant
Scott Laboratories, Inc
2804 n. loop 289
lubbock, TX 79415
PMA NumberP080009
Date Received03/25/2008
Decision Date05/03/2013
Product Code
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 
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