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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.
 
Trade NameCARDIOSEAL
Classification Nametranscatheter septal occluder
Generic Nameseptal occlusion system with qwik load
ApplicantNMT MEDICAL, INC.
PMA NumberP000049
Supplement NumberS002
Date Received01/11/2002
Decision Date04/19/2002
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement 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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