PMA P840064S017

Device: VISCOAT VISCOELASTIC SOLUTION
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S017
Product code: LZP
Decision date: 1996-06-21
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: 1)USE OF ALTERNATE STERILIZATION PROCESS USING 100% ETHYLENE OXIDE (ETO)/NITROGEN PURGE BY THE CONTRACT STERILIZER, STERI-TECH, INC. OF SALINAS, PUERTO RICO; 2)SHELF LIFE OF 24 MONTHS FOR VISCOAT AND 36 MONTHS FOR PROVISC; 3) ALTERNATE PACKAGING FOR PROVISC

Current openFDA PMA Record#

Device: VISCOAT VISCOELASTIC SOLUTION
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S017
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 1996-06-21
Decision code: APPR
Date received: 1995-12-26
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 1)USE OF ALTERNATE STERILIZATION PROCESS USING 100% ETHYLENE OXIDE (ETO)/NITROGEN PURGE BY THE CONTRACT STERILIZER, STERI-TECH, INC. OF SALINAS, PUERTO RICO; 2)SHELF LIFE OF 24 MONTHS FOR VISCOAT AND 36 MONTHS FOR PROVISC; 3) ALTERNATE PACKAGING FOR PROVISC