PMA P150010S001

Device
HYMOVIS
Applicant
Fidia Farmaceutici
PMA number
P150010
Supplement
S001
Product code
MOZ
Decision date
2016-11-22
Classification
Acid, Hyaluronic, Intraarticular
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Manufacturing process change to preparation of the principal bulk component.

Current openFDA PMA Record#

Device
HYMOVIS
Applicant
Fidia Farmaceutici
PMA number
P150010
Supplement
S001
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2016-11-22
Decision code
OK30
Date received
2016-10-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing process change to preparation of the principal bulk component.