PMA P250003S001
- Device
- Embrace(TM) Hydrogel Embolic System
- Applicant
- Instylla, Inc.
- PMA number
- P250003
- Supplement
- S001
- Product code
- QVG
- Decision date
- 2025-11-25
- Classification
- Cardiovascular
- Generic name
- Embolization Agent, Vascular
- Approval order statement
- approval to implement a minimum packaging configuration of 2 shelf boxes/shipper
Current openFDA PMA Record#
- Device
- Embrace(TM) Hydrogel Embolic System
- Applicant
- Instylla, Inc.
- PMA number
- P250003
- Supplement
- S001
- Product code
- QVG
- Generic name
- Embolization Agent, Vascular
- Decision date
- 2025-11-25
- Decision code
- APPR
- Date received
- 2025-09-11
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to implement a minimum packaging configuration of 2 shelf boxes/shipper