FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implantable Pulse Generator
PMA: P180036
·
Supplement: S030
·
Decision Jun 14, 2024
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Implantable Pulse Generator
- Trade Name
- OPTIMIZER Smart, Smart Mini, and Lite Systems
- PMA Number
- P180036
- Supplement Number
- S030
- Device Class
- FDA Class 3
- Product Code
- QFV
- Generic Name
- Implantable pulse generator
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 14, 2024
- Date Received
- May 31, 2024
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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%.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QFV | Implantable Pulse Generator | FDA class 3 | Unknown |