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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 NameADEPT ADHESION REDUCTION SOLUTION
Classification Namebarrier, absorable, adhesion
ApplicantBAXTER HEALTHCARE CORPORATION
PMA NumberP050011
Supplement NumberS003
Date Received04/24/2012
Decision Date05/17/2012
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee Obstetrics/Gynecology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the instructions for use to clarify that exsufflation should occur prior to instilling adept.
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