FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implantable Pulse Generator
PMA: P180036
·
Decision Mar 21, 2019
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Implantable Pulse Generator
- Trade Name
- OPTIMIZER Smart System
- PMA Number
- P180036
- 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
- March 21, 2019
- Date Received
- September 5, 2018
- Expedited Review
- N
- Docket Number
- 19M-1313
Advisory Committee 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%.
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 |