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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 NumberS001
Date Received06/27/2013
Decision Date06/16/2014
Withdrawal Date03/17/2025
Product Code PDR 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DESIGN MODIFICATIONS TO THE HARDWARE, FIRMWARE, AND SOFTWARE AND A NEW MANUFACTURING FACILITY AT FLEX MEDICAL IN TIJUANA, MEXICO.
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