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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
Classification Namecomputer-assisted personalized sedation system
Generic Namecomputer-assisted personalized sedation system
Applicant
Scott Laboratories, Inc
2804 n. loop 289
lubbock, TX 79415
PMA NumberP080009
Supplement NumberS001
Date Received06/27/2013
Decision Date06/16/2014
Product Code
PDR
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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