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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION
Classification Namebarrier, absorable, adhesion
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP050011
Date Received03/16/2005
Decision Date07/28/2006
Product Code
MCN[ Registered Establishments with MCN ]
Docket Number 06M-0322
Notice Date 08/17/2006
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 
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