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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 NameIMPELLA RP SYSTEM
Classification Nameright ventricular bypass (assist) device
Generic Nameright ventricular bypass (assist) device
Applicant
ABIOMED, INC.
22 cherry hill dr.
danvers, MA 01923
HDE NumberH140001
Supplement NumberS006
Date Received01/11/2016
Decision Date01/25/2016
Product Code
OJE[ Registered Establishments with OJE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
To add a second supplier for three sub-assemblies used to build the final impella purge cassette.
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