Rejoni, Inc.: PMA approval for Juveena Hydrogel System
Rejoni, Inc. (Bedford, Massachusetts): PMA approval for Juveena Hydrogel System. Dated 37 days ago, it serves as a historical benchmark. Score 55/100. 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: 36 related MA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Rejoni, Inc. |
| Product | Juveena Hydrogel System |
| Generic / ingredient | Barrier, absorbable, adhesion |
| Approval | PMA original approval (new class III device) |
| Application | P250051 |
| Decided | 2026-09-28 |
| Panel / class | Obstetrics/Gynecology |
| Sponsor location | Bedford, MA |
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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: 2026-09-28
- 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: Rejoni, Inc. and 37 Massachusetts peers
- Massachusetts FdaApprovalPulse records like this one: 37
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $7,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- A new product launch.
What is the FdaApprovalPulse record for Rejoni, Inc. in Bedford, Massachusetts?
The FDA approved Juveena Hydrogel System (P250051) for Rejoni, Inc. on 2026-09-28: PMA original approval (new class iii device).
How does Rejoni, Inc. compare to other Massachusetts FdaApprovalPulse records?
It is 37 days old, still within a typical 45-day follow-up window.
Rejoni, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Rejoni, Inc. | Bedford, MA | 2026-09-28 |
| Vivasure Medical , Ltd. | Galway | 2026-10-16 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-01 |
| Bard Peripheral Vascular, Inc. | Tempe, AZ | 2026-09-25 |
Related records
FdaApprovalPulse: PMA original approval (new class III device) FdaApprovalPulse: records in Massachusetts
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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.