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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 NumberS010
Date Received03/02/2004
Decision Date03/24/2004
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Change in manufacturing process of cardioseal septal occlusion system with quick load which involves a change to the bioburden sampling plan to eliminate redundant quarterly testing.
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