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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEMS
Classification Namecomputer-assisted personalized sedation system
ApplicantETHICON ENDO-SURGERY, INC.
PMA NumberP080009
Supplement NumberS004
Date Received01/29/2015
Decision Date03/23/2015
Product Code
PDR[ Registered Establishments with PDR ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the changes to the post-approval study protocol.
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