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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 NumberS001
Date Received09/08/2006
Decision Date11/08/2006
Product Code
LOZ[ Registered Establishments with LOZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the post-approval study (pas) design to continue to gather clinical data on the abiocor while it is commercialized. Specifically, the first consecutivetwenty-five (25) pati¢nts implanted with the abiocor will be enrolled into the pas and followed until death (while o~ the device) or other outcome (e. G. Elective termination by family, device malfunction, etc). Additionally, after the first 10 patients, the data maybe presented and reviewed by the circulatory systems devices panel.
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