Embrace(TM) Hydrogel Embolic System
FDA premarket approval P250003 · Embolization Agent, Vascular
PMA numberP250003
Approval
- Applicant
- Instylla, Inc.
- Received
- February 6, 2025
- Decision date
- August 5, 2025 (APPR)
- Supplements
- 7, latest September 3, 2026
- Product code
- QVG – Embolization Agent, Vascular
Approval order statement
The Embrace Hydrogel Embolic System (HES) is indicated for embolization of hypervascular tumors in peripheral arteries ? 5mm.