OPTIMIZER Smart System
FDA premarket approval P180036 · decided 2019-03-21
Approval details
- PMA number
- P180036
- Trade name
- OPTIMIZER Smart System
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2018-09-05
- Decision date
- 2019-03-21
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- 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%.
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