PMA P180036S030

Device: OPTIMIZER Smart, Smart Mini, and Lite Systems
Applicant: Impulse Dynamics (Usa), Inc.
PMA number: P180036
Supplement: S030
Product code: QFV
Decision date: 2024-06-14
Classification: Cardiovascular
Generic name: Implantable pulse generator
Approval order statement: approval to update the Indications for Use to: The OPTIMIZER [Smart, Smart Mini, Lite] System, which delivers Cardiac Contractility Modulation (CCM) therapy, is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, are not receiving Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.

Current openFDA PMA Record#

Device: OPTIMIZER Smart, Smart Mini, and Lite Systems
Applicant: Impulse Dynamics (Usa), Inc.
PMA number: P180036
Supplement: S030
Product code: QFV
Generic name: Implantable pulse generator
Decision date: 2024-06-14
Decision code: APPR
Date received: 2024-05-31
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval to update the Indications for Use to: The OPTIMIZER [Smart, Smart Mini, Lite] System, which delivers Cardiac Contractility Modulation (CCM) therapy, is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, are not receiving Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.