PMA P960011S005

Device: BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
Applicant: Altacor , Ltd.
PMA number: P960011
Supplement: S005
Product code: LZP
Decision date: 2000-05-19
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: Sterility release be based on review of documentation of the ethylene oxide sterilization cycle and testing of the biological indicators and that external sterility testing of Biolon syringe surfaces be discontinued.

Current openFDA PMA Record#

Device: BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
Applicant: Altacor , Ltd.
PMA number: P960011
Supplement: S005
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2000-05-19
Decision code: OK30
Date received: 2000-04-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Sterility release be based on review of documentation of the ethylene oxide sterilization cycle and testing of the biological indicators and that external sterility testing of Biolon syringe surfaces be discontinued.