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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 NumberS012
Date Received04/02/2004
Decision Date05/10/2004
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a warning to the labeling that protamine sulfate should not be used for heparin reversal because of the potential for thrombus formation.
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