PMA P030019S025

Device
Orthovisc
Applicant
Anika Therapeutics, Inc.
PMA number
P030019
Supplement
S025
Product code
MOZ
Decision date
2020-12-08
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
an alternate supplier of the glass syringes used in manufacture of the 2.25 and 3 mL sizes of ORTHOVISC

Current openFDA PMA Record#

Device
Orthovisc
Applicant
Anika Therapeutics, Inc.
PMA number
P030019
Supplement
S025
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2020-12-08
Decision code
OK30
Date received
2020-11-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
an alternate supplier of the glass syringes used in manufacture of the 2.25 and 3 mL sizes of ORTHOVISC