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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameABIOCOR IMPLANTABLE REPLACEMENT HEART
Classification Nameartificial heart
Generic Nameartificial heart
Applicant
Abiomed, Inc.
22 cherry hill dr.
danvers, MA 01923
HDE NumberH040006
Date Received09/02/2004
Decision Date09/05/2006
Product Code
LOZ[ Registered Establishments with LOZ ]
Docket Number 06M-0368
Advisory Committee Cardiovascular
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the abiocorh implantable replacement i leart. This dev ice is indicated for use in severe biventricularend stage heart disease patients who are not cardiac transplant candidates and who 1) are less than 75 years old; 2) require multiple inotropic support;3) are not treatable by lvad destination therapy; and 4) are not weanable from biventricular support if on such support.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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