• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
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
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 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
Supplements: S001 S002 S003 S004 S005 S007 S008 S009