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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 NumberS006
Date Received05/17/2017
Decision Date06/03/2019
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a transfer of the design-owning organization from Baxter AG Vienna, Austria to Baxter Alliance Park Braine-L'Alleud, Belgium and final release testing and product release functions from Baxter AG Vienna, Austria to Baxter Castlebar, Ireland for the ADEPT Adhesion Reduction Solution.
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