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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.
 
DeviceCARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD
Generic NameTranscatheter septal occluder
ApplicantNMT MEDICAL, INC.
27 WORMWOOD ST.
BOSTON, MA 02210
PMA NumberP000049
Supplement NumberS012
Date Received04/02/2004
Decision Date05/10/2004
Product Code MLV 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A WARNING TO THE LABELING THAT PROTAMINE SULFATE SHOULD NOT BE USED FOR HEPARIN REVERSAL BECAUSE OF THE POTENTIAL FOR THROMBUS FORMATION.
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