PMA P250003
- Device
- Embrace Hydrogel Embolic System (HES)
- Applicant
- Instylla, Inc.
- Product code
- QVG
- Decision date
- 2026-04-02
- Generic name
- Embolization Agent, Vascular
- Approval order statement
- a new design of the vial holder component of the HES Precursor Kit packaging
Current openFDA PMA Record#
- Device
- Embrace Hydrogel Embolic System (HES)
- Applicant
- Instylla, Inc.
- PMA number
- P250003
- Supplement
- S005
- Product code
- QVG
- Generic name
- Embolization Agent, Vascular
- Decision date
- 2026-04-02
- Decision code
- APPR
- Date received
- 2026-02-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a new design of the vial holder component of the HES Precursor Kit packaging