Seikagaku Corp.: PMA supplement approved for Gel-One
Seikagaku Corp. (Tokyo): PMA supplement approved for Gel-One. Dated 62 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: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Seikagaku Corp. |
| Product | Gel-One |
| Generic / ingredient | Acid, hyaluronic, intraarticular |
| Approval | PMA supplement (device change) |
| Application | P080020 S056 |
| Decided | 2026-09-04 |
| Panel / class | Orthopedic |
| Sponsor location | Tokyo |
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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: 2026-09-04
- 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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30 / 100 Score
What is the FdaApprovalPulse record for Seikagaku Corp. in Tokyo?
The FDA approved Gel-One (P080020 S056) for Seikagaku Corp. on 2026-09-04: PMA supplement (device change).
How does Seikagaku Corp. compare to other FdaApprovalPulse records?
It is 62 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.
Seikagaku Corp. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Seikagaku Corp. | Tokyo | 2026-09-04 |
| 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.