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Device | AMPLATZER MUSCULAR VSD OCCLUDER |
Generic Name | Transcatheter septal occluder |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P040040 |
Date Received | 09/30/2004 |
Decision Date | 09/07/2007 |
Product Code |
MLV |
Docket Number | 07M-0446 |
Notice Date | 11/19/2007 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE AMPLATZER MUSCULAR VSD OCCLUDER. THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH A COMPLEX VENTRICULAR SEPTAL DEFECT (VSD) OF SIGNIFICANT SIZE TO WARRANT CLOSURE (LARGE VOLUME LEFT TO RIGHT SHUNT, PULMONARY HYPERTENSION AND/OR CLINICAL SYMPTOMS OF CONGESTIVE HEART FAILURE) 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 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 S003 S004 S005 S006 S007 S008 S009 S012 S013 S014 S015 S016 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 |