PMA P100045S077

Device: CardioMEMS HF System
Applicant: ABBOTT MEDICAL
PMA number: P100045
Supplement: S077
Product code: MOM
Decision date: 2025-02-06
Classification: Cardiovascular
Generic name: System, hemodynamic, implantable
Approval order statement: approval for version C2.0 of the Merlin.net Patient Care Network (PCN) Heart Failure (HF) Portal and introduction of the CardioGuide HF Application for use with the CardioMEMS HF System.

Current openFDA PMA Record#

Device: CardioMEMS HF System
Applicant: ABBOTT MEDICAL
PMA number: P100045
Supplement: S077
Product code: MOM
Generic name: System, hemodynamic, implantable
Decision date: 2025-02-06
Decision code: APPR
Date received: 2024-07-05
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for version C2.0 of the Merlin.net Patient Care Network (PCN) Heart Failure (HF) Portal and introduction of the CardioGuide HF Application for use with the CardioMEMS HF System.