PMA P250009
- Device
- SQUID Liquid Embolic Agent (LEA)
- Applicant
- Balt USA, LLC
- PMA number
- P250009
- Supplement
- S002
- Product code
- SGU
- Decision date
- 2026-09-09
- Classification
- Neurology
- Generic name
- Neurovascular Liquid Embolic Agent
- Approval order statement
- Approval for changes to the mixing time for the SQUID Liquid Embolic Agent (LEA).
Current openFDA PMA Record#
- Device
- SQUID Liquid Embolic Agent (LEA)
- Applicant
- Balt USA, LLC
- PMA number
- P250009
- Supplement
- S002
- Product code
- SGU
- Generic name
- Neurovascular Liquid Embolic Agent
- Decision date
- 2026-09-09
- Decision code
- APPR
- Date received
- 2026-06-15
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the mixing time for the SQUID Liquid Embolic Agent (LEA).