PMA P250003S002

Device: Embrace™ Hydrogel Embolic System (HES)
Applicant: Instylla, Inc.
PMA number: P250003
Supplement: S002
Product code: QVG
Decision date: 2025-12-17
Classification: Cardiovascular
Generic name: Embolization Agent, Vascular
Approval order statement: to update to the PEG percent substitution test method, the Laysan Bio Manufacturing process for PEG, and process specifications by the steam sterilization supplier, Steris

Current openFDA PMA Record#

Device: Embrace™ Hydrogel Embolic System (HES)
Applicant: Instylla, Inc.
PMA number: P250003
Supplement: S002
Product code: QVG
Generic name: Embolization Agent, Vascular
Decision date: 2025-12-17
Decision code: OK30
Date received: 2025-11-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to update to the PEG percent substitution test method, the Laysan Bio Manufacturing process for PEG, and process specifications by the steam sterilization supplier, Steris