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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.
 
DeviceCOAPTITE INJECTABLE IMPLANT
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantMERZ NORTH AMERICA, INC
4133 COURTNEY ROAD
SUITE 10
FRANKSVILLE, WI 53126
PMA NumberP040047
Supplement NumberS007
Date Received06/30/2008
Decision Date07/24/2008
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGES IN THE METHOD USED TO MONITOR THE STERILIZATION CYCLE FOR THE COAPTITE® INJECTABLE IMPLANT FOR SOFT TISSUE AUGMENTATION.
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