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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.
 
DeviceOPTIMIZER Smart System
Classification Nameimplantable pulse generator
Generic Nameimplantable pulse generator
Applicant
Impulse Dynamics (USA), Inc.
30 ramland road south, suite 204
orangeburg, NY 10962
PMA NumberP180036
Date Received09/05/2018
Decision Date03/21/2019
Product Code
QFV[ Registered Establishments with QFV ]
Docket Number 19M-1313
Notice Date 03/22/2019
Advisory Committee Cardiovascular
Clinical Trials NCT01381172
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the OPTIMIZER Smart System. The device which delivers Cardiac Contractility Modulation therapy, is indicated to improve 6-minute hall walk distance, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for Cardiac Resynchronization Therapy, and have a left ventricular ejection fraction ranging from 25% to 45%.
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 
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