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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
Generic NameBarrier, absorbable, adhesion
ApplicantBaxter Healthcare Corp
1620 Waukegan Rd.
Mcgaw Park, IL 60085
PMA NumberP050011
Supplement NumberS008
Date Received04/13/2020
Decision Date08/21/2020
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for bag fill volume changes to the polyvinylchloride storage bag for the ADEPT® Adhesion Reduction Solution.
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