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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceImpella Ventricular Support Systems
Classification Nametemporary non-roller type left heart support blood pump
Generic Nametemporary non-roller type left heart support blood pump
Applicant
ABIOMED, INC.
22 cherry hill dr.
danvers, MA 01923
PMA NumberP140003
Supplement NumberS018
Date Received04/03/2017
Decision Date02/07/2018
Product Code
OZD[ Registered Establishments with OZD ]
Docket Number 18M-0620
Notice Date 02/09/2018
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Impella Ventricular Support Systems. The device is indicated for the treatment of ongoing cardiogenic shock that occurs:1) immediately (<48 hours) following acute myocardial infarction or open heart surgery; or2) in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis.As a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures.* The intent of the Impella Support Systems therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.*Optimal medical management and conventional treatment measures include volume loading and use of pressors and inotropes, with or without IABP.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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