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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION
Generic NameBarrier, absorbable, adhesion
ApplicantBAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK, IL 60085
PMA NumberP050011
Date Received03/16/2005
Decision Date07/28/2006
Product Code MCN 
Docket Number 06M-0322
Notice Date 08/17/2006
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION. THE DEVICE IS INDICATED FOR USE INTRAPERIOTONEALLY AS AN ADJUNCT TO GOOD SURGICAL TECHNIQUE FOR THE REDUCTION OF POST-SURGICAL ADHESIONS IN PATIENTS UNDERGOING GYNECOLOGICAL LAPAROSCOPIC ADHESIOLYSIS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
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