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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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
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