# ABBOTT MEDICAL: PMA supplement approved for CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Appl

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | ABBOTT MEDICAL |
| Product | CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Application (Model CM4000); HF Clo |
| Generic / ingredient | System, hemodynamic, implantable |
| Approval | PMA supplement (device change) |
| Application | P100045 S091 |
| Decided | 2026-09-30 |
| Panel / class | Cardiovascular |
| Sponsor location | Atlanta, GA |

## Why this score


Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S091). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.