PMA P980044S057

Device
SUPARTZ FX and VISCO-3
Applicant
Seikagaku Corp.
PMA number
P980044
Supplement
S057
Product code
MOZ
Decision date
2021-08-06
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Replacement of water ultrafiltration modules.

Current openFDA PMA Record#

Device
SUPARTZ FX and VISCO-3
Applicant
Seikagaku Corp.
PMA number
P980044
Supplement
S057
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2021-08-06
Decision code
OK30
Date received
2021-07-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of water ultrafiltration modules.