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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD
Generic NameTranscatheter septal occluder
ApplicantNMT MEDICAL, INC.
27 WORMWOOD ST.
BOSTON, MA 02210
PMA NumberP000049
Date Received11/21/2000
Decision Date12/05/2001
Product Code MLV 
Docket Number 02M-0272
Notice Date 06/27/2002
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD. THE SYSTEM IS INDICATED FOR USE IN PATIENTS WITH COMPLEX VENTRICULAR SEPTAL DEFECTS (VSD) OF SIGNIFICANT SIZE TO WARRANT CLOSURE WHO ARE CONSIDERED TO BE AT HIGH RISK FOR STANDARD TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE BASED ON ANATOMICAL CONDITIONS AND/OR BASED ON OVERALL MEDICAL CONDITION. HIGH RISK ANATOMICAL FACTORS FOR TRANSATRIAL OR TRANSARTERIAL SURGICAL CLOSURE INCLUDE PATIENTS: 1) REQUIRING A LEFT VENTRICULOTOMY OR AN EXTENSIVE RIGHT VENTRICULOTOMY; 2) WITH A FAILED PREVIOUS VSD CLOSURE; 3) WITH MULTIPLE APICAL AND/OR ANTERIOR MUSCULAR VSDS ("SWISS CHEESE SEPTUM"); OR 4) WITH POSTERIOR APICAL VSDS COVERED BY TRABECULAE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S004 S005 S006 S019 S001 S002 S009 S007 S016 S011 S012 
S013 S014 S015 
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