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Device | CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD |
Generic Name | Transcatheter septal occluder |
Applicant | NMT MEDICAL, INC. 27 WORMWOOD ST. BOSTON, MA 02210 |
PMA Number | P000049 |
Date Received | 11/21/2000 |
Decision Date | 12/05/2001 |
Product Code |
MLV |
Docket Number | 02M-0272 |
Notice Date | 06/27/2002 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S004 S005 S006 S007 S009 S011 S012 S013 S014 S015 S016 S019 |