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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.
 
DeviceAMPLATZER DUCT OCCLUDER
Generic NameOCCLUDER, PATENT DUCTUS, ARTERIOSUS
ApplicantAbbott Medical
177 County Road B East
St. Paul, MN 55117
PMA NumberP020024
Supplement NumberS023
Date Received02/11/2009
Decision Date04/08/2009
Product Code MAE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION IN PACKAGING MATERIALS AND THE USE OF A NEW SEALER TO ACCOMMODATE THE NEW PACKAGING MATERIALS.
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