PMA P950027S016

Device
HYALGAN®
Applicant
Fidia Farmaceutici S.P.A.
PMA number
P950027
Supplement
S016
Product code
MOZ
Decision date
2022-08-08
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Change from manual to automated syringe quality inspection.

Current openFDA PMA Record#

Device
HYALGAN®
Applicant
Fidia Farmaceutici S.P.A.
PMA number
P950027
Supplement
S016
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2022-08-08
Decision code
OK30
Date received
2022-07-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change from manual to automated syringe quality inspection.