Gyrus Acmi, Inc.: PMA supplement approved for Spiration® Valve System
Gyrus Acmi, Inc. (Redmond, Washington): PMA supplement approved for Spiration® Valve System. Dated 76 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: 5 related WA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Gyrus Acmi, Inc. |
| Product | Spiration® Valve System |
| Generic / ingredient | Valve, pulmonary |
| Approval | PMA supplement (device change) |
| Application | P180007 S016 |
| Decided | 2026-08-20 |
| Panel / class | Anesthesiology |
| Sponsor location | Redmond, WA |
| Peer records CSV (6 WA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-08-20
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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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: Gyrus Acmi, Inc. and 6 Washington peers
- Washington FdaApprovalPulse records like this one: 6
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Washington peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Gyrus Acmi, Inc. in Redmond, Washington?
The FDA approved Spiration® Valve System (P180007 S016) for Gyrus Acmi, Inc. on 2026-08-20: PMA supplement (device change).
How does Gyrus Acmi, Inc. compare to other Washington FdaApprovalPulse records?
It is 76 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.
Gyrus Acmi, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Gyrus Acmi, Inc. | Redmond, WA | 2026-08-20 |
| 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.