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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 NumberS024
Date Received03/06/2009
Decision Date12/23/2010
Product Code MAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR UPDATES TO THE LABELING OF THE AMPLATZER DUCT OCCLUDER TO REFLECT THE FINDINGS OF THE POST APPROVAL STUDY.
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