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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 NumberS005
Date Received07/21/2005
Decision Date10/13/2005
Product Code MAE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the labeling to support compatibility of the devices with MR environments up to 3.0 Tesla. The device, as modified, will be marketed under the trade name AMPLATZER Duct Occluder Device with the following indications for use: The AMPLATZER Duct Occluder Device is indicated for the non-surgical closure of patent ductus arteriosus (PDA).
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