OPTIMIZER Smart, Smart Mini, and Lite Systems
FDA premarket approval P180036/S030 · decided 2024-06-14
Approval details
- PMA number
- P180036
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OPTIMIZER Smart, Smart Mini, and Lite Systems
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2024-05-31
- Decision date
- 2024-06-14
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- 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%.
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