PMA supplement
P100045 S087: CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000))
FDA PMA supplement · Real-Time Process · ABBOTT MEDICAL
Key facts
| Original PMA | P100045 |
|---|---|
| Supplement number | S087 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | CardioMEMS™ HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000)) |
| Generic name | System, hemodynamic, implantable |
| Applicant | ABBOTT MEDICAL |
| Product code | MOM |
| Received date | Aug 29, 2025 |
| Decision date | Nov 10, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: