PMA P250003S006
- Device
- Embrace Hydrogel Embolic System (HES)
- Applicant
- Instylla, Inc.
- PMA number
- P250003
- Supplement
- S006
- Product code
- QVG
- Decision date
- 2026-04-01
- Classification
- Cardiovascular
- Generic name
- Embolization Agent, Vascular
- Approval order statement
- changes to the supplier of materials used in the Tyvek lid adhesive of the Embrace HES Accessory Kit packaging
Current openFDA PMA Record#
- Device
- Embrace Hydrogel Embolic System (HES)
- Applicant
- Instylla, Inc.
- PMA number
- P250003
- Supplement
- S006
- Product code
- QVG
- Generic name
- Embolization Agent, Vascular
- Decision date
- 2026-04-01
- Decision code
- OK30
- Date received
- 2026-03-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the supplier of materials used in the Tyvek lid adhesive of the Embrace HES Accessory Kit packaging