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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 LEFT VENTRICULAR SUPPORT SYSTEM
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 NumberS005
Date Received08/13/2015
Decision Date04/07/2016
Product Code
OZD[ Registered Establishments with OZD ]
Docket Number 16M-1165
Notice Date 05/11/2016
Advisory Committee Cardiovascular
Clinical Trials NCT00417378
NCT00562016
NCT00596726
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 2.5, Impella CP, Impella 5.0, and Impella LD catheters, in conjunction with the Automated Impella Controller, are temporary ventricular support devices intended for short term use (<= 4 days for the Impella 2.5 and Impella CP, and <=6 days for Impella 5.0 and LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction or open heart surgery 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 system 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
Post-Approval StudyShow Report Schedule and Study Progress
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