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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 MULTI-FENESTRATED SEPTAL OCCLUDER ? ?CRIBRIFORM? OCCLUDER
Generic NameOCCLUDER, PATENT DUCTUS, ARTERIOSUS
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP000039
Supplement NumberS013
Date Received11/21/2005
Decision Date09/21/2006
Product Code MAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER (?CRIBRIFORM? OCCLUDER). THE DEVICE IS INDICATED FOR THE CLOSURE OF MULTI-FENESTRATED (CRIBRIFORM) ATRIAL SEPTAL DEFECTS.
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