FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Hemodynamic, Implantable
PMA: P230040
·
Decision Jun 20, 2024
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- System, Hemodynamic, Implantable
- Trade Name
- Cordella Pulmonary Artery Sensor System (CorPASS)
- PMA Number
- P230040
- Device Class
- FDA Class 3
- Product Code
- MOM
- Generic Name
- System, hemodynamic, implantable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 20, 2024
- Date Received
- December 13, 2023
- Expedited Review
- N
- Docket Number
- 24M-2925
Advisory Committee Statement
The Cordella Pulmonary Artery Sensor System is intended to measure, record and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients who are at home on diuretics and guideline-directed medical therapy (GDMT) as well as have been stable for 30 days on GDMT. The device output is meant to aid clinicians in the assessment and management of heart failure, with the goal of reducing heart failure hospitalizations.
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 |
|---|---|---|---|
| MOM | System, Hemodynamic, Implantable | FDA class 3 | Unknown |