PMA P250003S004
- Device
- Embrace™ Hydrogel Embolic System (HES)
- Applicant
- Instylla, Inc.
- PMA number
- P250003
- Supplement
- S004
- Product code
- QVG
- Decision date
- 2026-02-12
- Classification
- Cardiovascular
- Generic name
- Embolization Agent, Vascular
- Approval order statement
- approval for a new marketing material
Current openFDA PMA Record#
- Device
- Embrace™ Hydrogel Embolic System (HES)
- Applicant
- Instylla, Inc.
- PMA number
- P250003
- Supplement
- S004
- Product code
- QVG
- Generic name
- Embolization Agent, Vascular
- Decision date
- 2026-02-12
- Decision code
- APPR
- Date received
- 2026-01-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a new marketing material