PMA P100045S087

Device: CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000))
Applicant: ABBOTT MEDICAL
PMA number: P100045
Supplement: S087
Product code: MOM
Decision date: 2025-11-10
Classification: Cardiovascular
Generic name: System, hemodynamic, implantable
Approval order statement: Approval for a software maintenance release (SMR 1.1) containing software modifications to the CardioMEMS HF System.

Current openFDA PMA Record#

Device: CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000))
Applicant: ABBOTT MEDICAL
PMA number: P100045
Supplement: S087
Product code: MOM
Generic name: System, hemodynamic, implantable
Decision date: 2025-11-10
Decision code: APPR
Date received: 2025-08-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a software maintenance release (SMR 1.1) containing software modifications to the CardioMEMS HF System.