PMA - Premarket Approval

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New Search Back to Search Results 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.   Trade Name AMPLATZER MUSCULAR VSD OCCLUDER Classification Name transcatheter septal occluder Generic Name device transcatheter cardiac occlusion Applicant AGA MEDICAL CORP. PMA Number P040040 Date Received 09/30/2004 Decision Date 09/07/2007 Product Code MLV [ Registered Establishments with MLV ] Docket Number 07M-0446 Notice Date 11/19/2007 Advisory Committee Cardiovascular Expedited Review Granted? No Information About: Labeling, Approval Order, Summary of Safety and Effectiveness 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. Post-Approval Study Show Report Schedule and Study Progress Supplements: S001 S002 S003 S004 S005 S006  S007 S008 S009