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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.
 
DeviceSTARFLEX SEPTAL OCCLUSION SYSTEM
Generic NameTranscatheter septal occluder
ApplicantNMT MEDICAL, INC.
27 WORMWOOD ST.
BOSTON, MA 02210
PMA NumberP000049
Supplement NumberS016
Date Received03/02/2006
Decision Date03/05/2009
Product Code MLV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE STARFLEX VSD OCCLUDER IN THREE SIZES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STARFLEX SEPTAL OCCLUDER AND IS INDICATED FOR USE IN PATIENTS WITH A COMPLEX VENTRICULAR SEPTAL DEFECT (VSD) OF A SIGNIFICANT SIZE TO WARRANT CLOSURE, BUT THAT BASED ON LOCATION, CANNOT BE CLOSED WITH STANDARD TRANSATRIAL OR TRANSARTERIAL APPROACHES.
Post-Approval StudyShow Report Schedule and Study Progress
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