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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.
Classification Nameright ventricular bypass (assist) device
Generic Nameright ventricular bypass (assist) device
22 cherry hill dr.
danvers, MA 01923
HDE NumberH140001
Supplement NumberS001
Date Received02/09/2015
Decision Date03/03/2015
Product Code
OJE[ Registered Establishments with OJE ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason request for adn
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval in accordance with 613(b) of the food and drug administrationsafety and innovation act (fdasia), a determination that your humanitarian use device (hud) meets the conditions of either subclause (i) or (ii) under section 520(m)(6)(a)(i) of the federal food, drug, and cosmetic act (fd&c act), as amended by the fdasia, so that your devicemay be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i. E. , for profit). The adn for this device has been determined to be 4,000.