# Instylla, Inc.: PMA supplement approved for Embrace(TM) Hydrogel Embolic System

**Score:** 60/100

| Field | Value |
|---|---|
| Sponsor | Instylla, Inc. |
| Product | Embrace(TM) Hydrogel Embolic System |
| Generic / ingredient | Embolization Agent, Vascular |
| Approval | PMA supplement (device change) |
| Application | P250003 S010 |
| Decided | 2026-10-21 |
| Panel / class | Cardiovascular |
| Sponsor location | Bedford, MA |

## Why this score
- Decided in the last 30 days.

Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250003S010). Last refreshed: 2026-11-04T06:06:18.796Z.
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.