PMA approvals

SQUID Liquid Embolic Agent (LEA)

Balt USA, LLC · Neurovascular Liquid Embolic Agent · Neurology

P250009 S001SupplementApproved
Open FDA's page for this record
PMA number
P250009
Supplement number
S001
Applicant
Balt USA, LLC
Street 1
29 Parker
City
Irvine
State
CA
Zip
92618
Generic name
Neurovascular Liquid Embolic Agent
Trade name
SQUID Liquid Embolic Agent (LEA)
Product code
SGU
Advisory committee
NE
Advisory committee description
Neurology
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Expedited review flag
N
Date received
2026-03-06
Decision date
2026-10-16
Decision code
APPR
Ao 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.

Harmonized identifiers (openFDA)
Device name
Neurovascular Liquid Embolic Agent
Medical specialty description
Unknown
Device class
3
Registration number
3015550451, 2029214, 3008114965, 3009380063, 3014162263, 1226348, 3007628272
FEI number
3015550451, 3002947440, 1000220862, 3008114965, 3009380063, 3014162263, 3007628272
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.