PMA P250009
- Device
- SQUID Liquid Embolic Agent (LEA)
- Applicant
- Balt USA, LLC
- PMA number
- P250009
- Product code
- SGU
- Decision date
- 2026-01-30
- Classification
- Neurology
- Generic name
- Neurovascular Liquid Embolic Agent
- Approval order statement
- The SQUID Liquid Embolic Agent is indicated for the embolization of the middle meningeal artery (MMA) as an adjunct to usual care treatment in patients with symptomatic chronic subdural hematoma(s) (SDH) measuring 10 mm or greater in thickness in whom an intervention is deemed necessary as determined by a neurosurgeon.
Current openFDA PMA Record#
- Device
- SQUID Liquid Embolic Agent (LEA)
- Applicant
- Balt USA, LLC
- PMA number
- P250009
- Product code
- SGU
- Generic name
- Neurovascular Liquid Embolic Agent
- Decision date
- 2026-01-30
- Decision code
- APPR
- Date received
- 2025-03-21
- Approval order statement
- The SQUID Liquid Embolic Agent is indicated for the embolization of the middle meningeal artery (MMA) as an adjunct to usual care treatment in patients with symptomatic chronic subdural hematoma(s) (SDH) measuring 10 mm or greater in thickness in whom an intervention is deemed necessary as determined by a neurosurgeon.