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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameCARDIOSEAL SEPTAL OCCLUSION SYSTEM
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
Applicant
Nitinol Medical Technologies, Inc.
27 wormwood st.
boston, MA 02210
HDE NumberH990011
Supplement NumberS011
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 ProductNo
Approval Order Statement 
Addition of a warning to the labeling that protamine sulfate should not beused for heparin reversal because of the potential for thrombus formation.
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