PMA P220020S006

Device
Lava Liquid Embolic System (Lava LES)
Applicant
Sirtex Medical, Inc.
PMA number
P220020
Supplement
S006
Product code
QVG
Decision date
2025-06-02
Classification
Cardiovascular
Generic name
Embolization Agent, Vascular
Approval order statement
a change in shipping from overnight to two-day delivery

Current openFDA PMA Record#

Device
Lava Liquid Embolic System (Lava LES)
Applicant
Sirtex Medical, Inc.
PMA number
P220020
Supplement
S006
Product code
QVG
Generic name
Embolization Agent, Vascular
Decision date
2025-06-02
Decision code
OK30
Date received
2025-05-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a change in shipping from overnight to two-day delivery