PMA P980044S045

Device
Supartz FX, Visco-3
Applicant
Seikagaku Corp.
PMA number
P980044
Supplement
S045
Product code
MOZ
Decision date
2018-05-25
Classification
Acid, Hyaluronic, Intraarticular
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Installation of a clean booth to be used in the processing of a syringe component for SUPARTZ FX and VISCO-3.

Current openFDA PMA Record#

Device
Supartz FX, Visco-3
Applicant
Seikagaku Corp.
PMA number
P980044
Supplement
S045
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2018-05-25
Decision code
OK30
Date received
2018-04-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Installation of a clean booth to be used in the processing of a syringe component for SUPARTZ FX and VISCO-3.