PMA P000046S032

Device: Ophthalmic Viscosurgical Device Family
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S032
Product code: LZP
Decision date: 2026-08-28
Classification: Ophthalmic
Generic name: AID, SURGICAL, VISCOELASTIC
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: Ophthalmic Viscosurgical Device Family
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S032
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
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