PMA P980044S054

Device
SUPARTZ FX, VISCO-3
Applicant
Seikagaku Corp.
PMA number
P980044
Supplement
S054
Product code
MOZ
Decision date
2020-11-12
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Replacement of the filter integrity test system.

Current openFDA PMA Record#

Device
SUPARTZ FX, VISCO-3
Applicant
Seikagaku Corp.
PMA number
P980044
Supplement
S054
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2020-11-12
Decision code
OK30
Date received
2020-10-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of the filter integrity test system.