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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.
 
DeviceAMPLATZER MUSCULAR VSD OCCLUDER
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
Applicant
AGA MEDICAL CORP.
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 
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