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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 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
Date Received09/10/2014
Decision Date01/23/2015
Product Code
OJE[ Registered Establishments with OJE ]
Docket Number 15M-0267
Notice Date 02/09/2015
Advisory Committee Cardiovascular
Clinical Trials NCT01777607
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the impella rp system. This device is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area >=1. 5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 
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