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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 NumberS001
Date Received01/09/2008
Decision Date02/07/2008
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
RELOCATION OF THE QUALITY SYSTEM TO BAXTER AG, VIENNA, AUSTRIA AND CHANGING THE CONTRACT TEST LABORATORY TO THE MATERIAL MANUFACTURER CARGILL?S TESTING LABORATORY.
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