PMA P030019S028

Device: Orthovisc Injectable Intra-Articular Devices
Applicant: Anika Therapeutics, Inc.
PMA number: P030019
Supplement: S028
Product code: MOZ
Decision date: 2026-08-28
Classification: Orthopedic
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: the replacement of reusable components with single-use, presterilized components for use during transfer steps of the formulation and fill process during manufacturing of the subject sodium hyaluronate devices

Current openFDA PMA Record#

Device: Orthovisc Injectable Intra-Articular Devices
Applicant: Anika Therapeutics, Inc.
PMA number: P030019
Supplement: S028
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2026-08-28
Decision code: OK30
Date received: 2026-07-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the replacement of reusable components with single-use, presterilized components for use during transfer steps of the formulation and fill process during manufacturing of the subject sodium hyaluronate devices