Instylla, Inc.: PMA supplement approved for Embrace® Hydrogel Embolic System
Instylla, Inc. (Bedford, Massachusetts): PMA supplement approved for Embrace® Hydrogel Embolic System. Dated 13 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: 36 related MA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Instylla, Inc. |
| Product | Embrace® Hydrogel Embolic System |
| Generic / ingredient | Embolization Agent, Vascular |
| Approval | PMA supplement (device change) |
| Application | P250003 S011 |
| Decided | 2026-10-23 |
| Panel / class | Cardiovascular |
| 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: 2026-10-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (MA first): Instylla, Inc. · Instylla, Inc. · ZOLL Medical Corporation · Pramand, LLC · Rejoni, 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: Instylla, Inc. and 37 Massachusetts peers
- Massachusetts FdaApprovalPulse records like this one: 37
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Massachusetts peer: $7,400 (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 Instylla, Inc. in Bedford, Massachusetts?
The FDA approved Embrace® Hydrogel Embolic System (P250003 S011) for Instylla, Inc. on 2026-10-23: PMA supplement (device change).
How does Instylla, Inc. compare to other Massachusetts FdaApprovalPulse records?
It is fresh: dated 13 days ago, inside the window where early outreach matters most.
Instylla, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| 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 |
| Advanced Medical Solutions Limited | Plymouth | 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.