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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 SEPTAL OCCLUDER
Generic NameOCCLUDER, PATENT DUCTUS, ARTERIOSUS
ApplicantAbbott Medical
177 County Road B East
St. Paul, MN 55117
PMA NumberP000039
Supplement NumberS002
Date Received03/12/2002
Decision Date05/03/2002
Product Code MAE 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A CAUTION LABEL.
Post-Approval StudyShow Report Schedule and Study Progress
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