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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 NameABIOCOR
Classification Nameartificial heart
Generic Nameartificial heart
Applicant
Abiomed, Inc.
22 cherry hill dr.
danvers, MA 01923
HDE NumberH040006
Supplement NumberS002
Date Received03/02/2007
Decision Date01/17/2008
Product Code
LOZ[ Registered Establishments with LOZ ]
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 specific hardware and software modifications to the abiocor@d device. These hardware and software modifications were specifically described inthe executive summary and in the abiocor@ modifications table.
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