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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
Generic NameComputer-assisted personalized sedation system
ApplicantScott Laboratories, Inc.
2804 N. Loop 289
Lubbock, TX 79415
PMA NumberP080009
Supplement NumberS009
Date Received09/08/2015
Decision Date10/08/2015
Withdrawal Date03/17/2025
Product Code PDR 
Advisory Committee Anesthesiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE CLINICAL USER GUIDE/ OPERATOR¿S MANUAL TO WARN AGAINST THE USE OF QUATERNARY AMMONIUM COMPOUND (QAC)-BASED DISINFECTANTS (SPECIFICALLY THOSE CONTAINING AMMONIUM CHLORIDES). ADDITIONALLY, AFFIXING TWO LABELS TO THE EXTERIOR OF THE DEVICE WHICH REITERATE THIS WARNING.
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