Identity
- Trade Name
- CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM FDA PMA
- Generic Name
- System, hemodynamic, implantable FDA PMA
Identifiers
- PMA Number
- P100045 FDA PMA
- FDA Product Code
- MOM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The CardioMEMS HF System is an implantable hemodynamic monitoring system designed to wirelessly measure and monitor pulmonary artery (PA) pressure and heart rate. It includes the CM2000 implantable PA sensor/monitor, transvenous catheter delivery system, patient electronics systems (CM1000, CM1010), and hospital electronics system (CM3000).
This system is indicated for use in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. Hemodynamic data are used by physicians for heart failure management with the goal of reducing heart failure hospitalizations. The device is supplied as an implantable system and requires surgical implantation for use.
Frequently asked questions
What does the CardioMEMS HF System measure?
The CardioMEMS HF System wirelessly measures and monitors pulmonary artery (PA) pressure and heart rate in patients with heart failure.
Who is the CardioMEMS HF System intended for?
The system is indicated for New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year.
What components are included in the CardioMEMS HF System?
The system includes the CM2000 implantable PA sensor/monitor, transvenous catheter delivery system, CM1000 and CM1010 patient electronics systems (GSM), and the CM3000 hospital electronics system.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100045 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P100045 24 fields · synced Sep 18, 2026