PMA P100045S091

Device: CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Application (Model CM4000); HF Clo
Applicant: ABBOTT MEDICAL
PMA number: P100045
Supplement: S091
Product code: MOM
Decision date: 2026-09-30
Classification: Cardiovascular
Generic name: System, hemodynamic, implantable
Approval order statement: proposed modifications to the Merlin.net Patient Care Network (PCN) Heart Failure (HF) Portal (Model MN6000) and the CardioMEMS Backend Web Application (Model CM4000), that comprise the HF Cloud Software Version C2.1 update.

Current openFDA PMA Record#

Device: CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Application (Model CM4000); HF Clo
Applicant: ABBOTT MEDICAL
PMA number: P100045
Supplement: S091
Product code: MOM
Generic name: System, hemodynamic, implantable
Decision date: 2026-09-30
Decision code: APPR
Date received: 2026-07-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: proposed modifications to the Merlin.net Patient Care Network (PCN) Heart Failure (HF) Portal (Model MN6000) and the CardioMEMS Backend Web Application (Model CM4000), that comprise the HF Cloud Software Version C2.1 update.