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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 NumberS002
Date Received06/05/2015
Decision Date06/17/2015
Product Code
OJE[ Registered Establishments with OJE ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the implementation of additional quality control measurements for fluid tightness of the impella purge cassette.
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