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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.
 
DeviceADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
Generic NameBarrier, absorbable, adhesion
ApplicantBAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK, IL 60085
PMA NumberP050011
Supplement NumberS002
Date Received11/03/2010
Decision Date06/17/2011
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO IMPLEMENT THE ASSAY FOR DETECTING THE AMOUNT OF PEPTIDOGLYCAN (PG) IN THE ICODEXTRIN ACTIVE PHARMACEUTICAL INGREDIENT (API).
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