PMA P000046S024

Device: STAARVISC, OPTIVISC AND ANIKAVISC SODIUM HYALURONATE
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S024
Product code: LZP
Decision date: 2014-06-24
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: CHANGE TO THE QUALITY CONTROL METHOD FOR REDUCED TESTING FOR ANIKA¿SOPHTHALMIC DEVICES: STAARVISC, OPTIVISC, NUVISC, AND ANIKAVISC SODIUM HYALURONATE AT THE POSTFILL STAGE.

Current openFDA PMA Record#

Device: STAARVISC, OPTIVISC AND ANIKAVISC SODIUM HYALURONATE
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S024
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2014-06-24
Decision code: OK30
Date received: 2014-06-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE QUALITY CONTROL METHOD FOR REDUCED TESTING FOR ANIKA¿SOPHTHALMIC DEVICES: STAARVISC, OPTIVISC, NUVISC, AND ANIKAVISC SODIUM HYALURONATE AT THE POSTFILL STAGE.