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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 Rd.
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
Predetermined Change Control Plan AuthorizedNo
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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