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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 II
Generic NameOCCLUDER, PATENT DUCTUS, ARTERIOSUS
ApplicantAbbott Medical
177 County Road B East
St. Paul, MN 55117
PMA NumberP020024
Supplement NumberS037
Date Received01/22/2013
Decision Date08/18/2013
Product Code MAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE SECOND GENERATION AMPLATZER DUCT OCCLUDER II (ADO II) DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPLATZER DUCT OCCLUDER II AND IS INDICATED FOR THE NON-SURGICAL CLOSURE OF PATENT DUCTUS ARTERIOSIUS (PDA).
Post-Approval StudyShow Report Schedule and Study Progress
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