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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 NumberS011
Date Received11/18/2015
Decision Date02/12/2016
Product Code PDR 
Advisory Committee Anesthesiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for software changes to pulse oximeter artifact mitigation period, redundant pulse oximetry signal quality advisory, allotted time for pulse oximeter synchronization (reset and return to normal operation), and the ability to select Clinician Response (manual) mode after starting treatment using automated response mode.
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