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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA 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
Supplement NumberS016
Date Received03/02/2006
Decision Date03/05/2009
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the starflex vsd occluder in three sizes. The device, as modified, will be marketed under the trade name starflex septal occluder and is indicated for use in patients with a complex ventricular septal defect (vsd) of a significant size to warrant closure, but that based on location, cannot be closed with standard transatrial or transarterial approaches.
Post-Approval StudyShow Report Schedule and Study Progress