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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 NumberS012
Date Received12/17/2015
Decision Date03/15/2016
Withdrawal Date03/17/2025
Product Code PDR 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for software changes to address previous software anomalies (modifications to the Bedside Monitoring Unit (BMU) software to address wireless driver-caused shutdowns, BMU software modifications to address noninvasive blood pressure (NIBP) measurements).
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