Atlas FDA

CardioMEMs HF System

FDA premarket approval P100045/S056 · decided 2022-02-18

Approval details

PMA number
P100045
Supplement
S056
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
CardioMEMs HF System
Generic name
System, hemodynamic, implantable
Applicant
ABBOTT MEDICAL
Date received
2021-07-01
Decision date
2022-02-18
Days to decision
232 days
Decision code
APPR
Product code
MOM
Advisory committee
Cardiovascular
Expedited review
No
Location
Atlanta, GA
Statement
Approval for the CardioMEMS HF System. The device is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data are used by physicians for heart failure management with the goal of controlling pulmonary artery pressures and reducing heart failure hospitalizations.

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