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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
27 wormwood st.
boston, MA 02210
PMA NumberP000049
Date Received11/21/2000
Decision Date12/05/2001
Product Code
MLV[ Registered Establishments with 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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S007 S009 S011 S012 
S013 S014 S015 S016 S019