PMA P980044S058

Device
SUPARTZ FX, VISCO-3
Applicant
Seikagaku Corp.
PMA number
P980044
Supplement
S058
Product code
MOZ
Decision date
2021-11-17
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Use of a new polarimeter for acceptance testing of hyaluronic acid (HA) and D-glucuronolactone.

Current openFDA PMA Record#

Device
SUPARTZ FX, VISCO-3
Applicant
Seikagaku Corp.
PMA number
P980044
Supplement
S058
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2021-11-17
Decision code
OK30
Date received
2021-10-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of a new polarimeter for acceptance testing of hyaluronic acid (HA) and D-glucuronolactone.