PMA P250009S001

Device: SQUID Liquid Embolic Agent (LEA)
Applicant: Balt USA, LLC
PMA number: P250009
Supplement: S001
Product code: SGU
Decision date: 2026-10-16
Classification: Neurology
Generic name: Neurovascular Liquid Embolic Agent
Approval order statement: Approval of the protocol for the COSMIC post-approval study (PAS). The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250009.

Current openFDA PMA Record#

Device: SQUID Liquid Embolic Agent (LEA)
Applicant: Balt USA, LLC
PMA number: P250009
Supplement: S001
Product code: SGU
Generic name: Neurovascular Liquid Embolic Agent
Decision date: 2026-10-16
Decision code: APPR
Date received: 2026-03-06
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the protocol for the COSMIC post-approval study (PAS). The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250009.