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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
St. Jude Medical Cardiovascular Division
5050 nathan lane north
plymouth, MN 55442
PMA NumberP040040
Date Received09/30/2004
Decision Date09/07/2007
Product Code
MLV[ Registered Establishments with 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
Post-Approval StudyShow 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