W. L. Gore & Associates, Inc.: PMA supplement approved for GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
W. L. Gore & Associates, Inc. (Flagstaff, Arizona): PMA supplement approved for GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. Dated 28 days ago, it is in the active follow-up window. Score 60/100. 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 | W. L. Gore & Associates, Inc. |
| Product | GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis |
| Generic / ingredient | Iliac covered stent, arterial |
| Approval | PMA supplement (device change) |
| Application | P160021 S051 |
| Decided | 2026-10-08 |
| Panel / class | Cardiovascular |
| Sponsor location | Flagstaff, AZ |
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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: 2026-10-08
- 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) · Bard Peripheral Vascular, Inc. · Ventana Medical Systems, 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: W. L. Gore & Associates, Inc. and 18 Arizona peers
- Arizona FdaApprovalPulse records like this one: 18
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Arizona peer: $3,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
60 / 100 Score
- Decided in the last 30 days.
What is the FdaApprovalPulse record for W. L. Gore & Associates, Inc. in Flagstaff, Arizona?
The FDA approved GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021 S051) for W. L. Gore & Associates, Inc. on 2026-10-08: PMA supplement (device change).
How does W. L. Gore & Associates, Inc. compare to other Arizona FdaApprovalPulse records?
It is 28 days old, still within a typical 45-day follow-up window.
W. L. Gore & Associates, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| W. L. Gore & Associates, Inc. | Flagstaff, AZ | 2026-10-08 |
| 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.