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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 NumberH990005
Supplement NumberS002
Date Received05/22/2000
Decision Date08/04/2000
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a modified loading system.
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