PMA P150010S004

Device
HYMOVIS® (High Molecular Weight Viscoelastic Hyaluronan)
Applicant
Fidia Farmaceutici
PMA number
P150010
Supplement
S004
Product code
MOZ
Decision date
2024-10-16
Classification
Orthopedic
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Change to introduce an additional new filling and stoppering machine

Current openFDA PMA Record#

Device
HYMOVIS® (High Molecular Weight Viscoelastic Hyaluronan)
Applicant
Fidia Farmaceutici
PMA number
P150010
Supplement
S004
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2024-10-16
Decision code
OK30
Date received
2024-09-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to introduce an additional new filling and stoppering machine