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Device | IMPELLA VENTRICULAR SUPPORT SYSTEMS |
Generic Name | Temporary non-roller type left heart support blood pump |
Applicant | ABIOMED, INC. 22 CHERRY HILL DR. DANVERS, MA 01923 |
PMA Number | P140003 |
Supplement Number | S004 |
Date Received | 08/12/2015 |
Decision Date | 04/07/2016 |
Product Code |
OZD |
Docket Number | 16M-1915 |
Notice Date | 07/05/2016 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00417378
|
Supplement Type | Panel 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 the Impella 5.0 and Impella 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 measures include volume loading, use of pressors and inotropes support with or without IABP. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |