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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceImpella RP System
Classification Nametemporary non-roller type right heart support blood pump
Generic Nametemporary non-roller type right heart support blood pump
Regulation Number870.4360
Applicant
Abiomed, Inc.
22 cherry hill drive
danvers, MA 01923
PMA NumberP170011
Date Received03/30/2017
Decision Date09/20/2017
Product Code
PYX[ Registered Establishments with PYX ]
Docket Number 17M-5884
Notice Date 09/22/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01777607
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Impella RP® System. This device is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area greater than or equal to 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 Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 
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