ABBOTT MEDICAL: PMA supplement approved for CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Appl
ABBOTT MEDICAL (Atlanta, Georgia): PMA supplement approved for CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Appl. Dated 35 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 3 related GA FdaApprovalPulse records and the 4-column CSV export.
| 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 |
| Peer records CSV (4 GA records) | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-09-30
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (GA first): Cryolife, Inc. · Artivion, Inc. · ABBOTT MEDICAL · Instylla, Inc. · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: ABBOTT MEDICAL and 4 Georgia peers
- Georgia FdaApprovalPulse records like this one: 4
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Georgia peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for ABBOTT MEDICAL in Atlanta, Georgia?
The FDA approved CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Application (Model CM4000); HF Clo (P100045 S091) for ABBOTT MEDICAL on 2026-09-30: PMA supplement (device change).
How does ABBOTT MEDICAL compare to other Georgia FdaApprovalPulse records?
It is 35 days old, still within a typical 45-day follow-up window. Its Score of 30/100 is modest; treat it as background rather than a priority.
ABBOTT MEDICAL vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| ABBOTT MEDICAL | Atlanta, GA | 2026-09-30 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
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FdaApprovalPulse: PMA supplement (device change) FdaApprovalPulse: records in Georgia
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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.