Cardiomems HF Pressure Measurement System

FDA premarket approval P100045 · System, hemodynamic, implantable

PMA numberP100045

Approval

Applicant
Abbott Medical
Received
December 15, 2010
Decision date
May 28, 2014 (APPR)
Supplements
88, latest September 11, 2026
Product code
MOM – System, Hemodynamic, Implantable

Official FDA PMA record

Approval order statement

APPROVAL FOR THE CARDIOMEMS HF SYSTEM, WHICH INCLUDES THE CM2000 IMPLANTABLE PA SENSOR/MONITOR AND TRANSVENOUS CATHETER DELIVERY SYSTEM, THE CM1000 PATIENT ELECTRONICS SYSTEM (GSM), THECM1010 PATIENT ELECTRONICS SYSTEM (GSM), AND CM3000 HOSPITAL ELECTRONICS SYSTEM. THIS DEVICE IS INDICATED FOR WIRELESSLY MEASURING AND MONITORING PULMONARY ARTERY (PA) PRESSURE AND HEART RATE IN NEW YORK HEART ASSOCIATION (NYHA) CLASS III HEART FAILURE PATIENTS WHO HAVE BEEN HOSPITALIZED FOR HEART FAILURE IN THE PREVIOUS YEAR. THE HEMODYNAMIC DATA ARE USED BY PHYSICIANS FOR HEART FAILURE MANAGEMENT AND WITH THE GOAL OF REDUCING HEART FAILURE HOSPITALIZATIONS.