PMA P000046S025

Device: OPHTHALMICS- ANIKAVISC, OPTIVISC AND NUVISC
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S025
Product code: LZP
Decision date: 2014-07-08
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: CHANGE TO THE SYRINGE RESIDUAL SOLVENT TESTING FROM A SUPPLIERS CONTRACT LABORATORY TO THE SUPPLIERS IN-HOUSE FACILITY FOR ANIKAS OPHTHALMIC DEVICES.

Current openFDA PMA Record#

Device: OPHTHALMICS- ANIKAVISC, OPTIVISC AND NUVISC
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S025
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2014-07-08
Decision code: OK30
Date received: 2014-06-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE SYRINGE RESIDUAL SOLVENT TESTING FROM A SUPPLIERS CONTRACT LABORATORY TO THE SUPPLIERS IN-HOUSE FACILITY FOR ANIKAS OPHTHALMIC DEVICES.