PMA P000046S015

Device: STAARVISC II & SHELLGEL SODIUM HYAURONATE
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S015
Product code: LZP
Decision date: 2012-03-27
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR A MANUFACTURING SITE CHANGE FROM THE PREVIOUS FACILITY IN WEST CUMMINGS PARK, WOBURN, MASSACHUSETTS TO THE NEW FACILITY LOCATED IN BEDFORD, MASSACHUSETTS. IN ADDITION, THE SUPPLEMENT REQUESTED APPROVAL TO CHANGE THE TERMINAL STERILIZATION METHOD OF THE PRODUCT FROM E-BEAM CONTROLLED DEPTH STERILIZATION TO VAPORIZED HYDROGEN PEROXIDE (VHP) GAS STERILIZATION.

Current openFDA PMA Record#

Device: STAARVISC II & SHELLGEL SODIUM HYAURONATE
Applicant: Anika Therapeutics, Inc.
PMA number: P000046
Supplement: S015
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2012-03-27
Decision code: APPR
Date received: 2009-05-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MANUFACTURING SITE CHANGE FROM THE PREVIOUS FACILITY IN WEST CUMMINGS PARK, WOBURN, MASSACHUSETTS TO THE NEW FACILITY LOCATED IN BEDFORD, MASSACHUSETTS. IN ADDITION, THE SUPPLEMENT REQUESTED APPROVAL TO CHANGE THE TERMINAL STERILIZATION METHOD OF THE PRODUCT FROM E-BEAM CONTROLLED DEPTH STERILIZATION TO VAPORIZED HYDROGEN PEROXIDE (VHP) GAS STERILIZATION.