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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.
 
DeviceCARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
Applicant
NMT MEDICAL, INC.
27 wormwood st.
boston, MA 02210
PMA NumberP000049
Supplement NumberS001
Date Received01/10/2002
Decision Date04/19/2002
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post-approval study protocol for the cardioseal septal occlusion system with qwikload.
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