Ventana Medical Systems, Inc.: PMA supplement approved for PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc. (Tucson, Arizona): PMA supplement approved for PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody. Dated 173 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: 17 related AZ FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Ventana Medical Systems, Inc. |
| Product | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody |
| Generic / ingredient | SYSTEM, TEST, HER-2/NEU, IHC |
| Approval | PMA supplement (device change) |
| Application | P990081 S058 |
| Decided | 2026-05-15 |
| Panel / class | Pathology |
| Sponsor location | Tucson, AZ |
| Peer records CSV (18 AZ 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: 2026-05-15
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (AZ first): Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Ventana Medical Systems · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · W. L. Gore & Associates, Inc. · Bard Peripheral Vascular, Inc. · 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: Ventana Medical Systems, Inc. and 18 Arizona peers
- Arizona FdaApprovalPulse records like this one: 18
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Arizona peer: $3,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Ventana Medical Systems, Inc. in Tucson, Arizona?
The FDA approved PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081 S058) for Ventana Medical Systems, Inc. on 2026-05-15: PMA supplement (device change).
How does Ventana Medical Systems, Inc. compare to other Arizona FdaApprovalPulse records?
It is 173 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Ventana Medical Systems, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Ventana Medical Systems, Inc. | Tucson, AZ | 2026-05-15 |
| 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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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.