PMA P840064S019

Device: VISCOAT VISCOELASTIC SOLUTION
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S019
Product code: LZP
Decision date: 1998-03-17
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR THE INCORPORATION OF VISCOAT AND PROVISC, WHICH MAKE UP THE DUOVISC PRODUCT, INTO A SINGLE PLASTIC TRAY, TO BE STERILIZED AND PROCESSED AT ALCON'S PUERTO RICO FACILITY; AND A CHANGE IN THE STERILIZATION PROCESS AT ALCON'S PUERTO RICO FACILITY FOR THE DUOVISC SYSTEM.

Current openFDA PMA Record#

Device: VISCOAT VISCOELASTIC SOLUTION
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S019
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 1998-03-17
Decision code: APPR
Date received: 1996-12-04
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE INCORPORATION OF VISCOAT AND PROVISC, WHICH MAKE UP THE DUOVISC PRODUCT, INTO A SINGLE PLASTIC TRAY, TO BE STERILIZED AND PROCESSED AT ALCON'S PUERTO RICO FACILITY; AND A CHANGE IN THE STERILIZATION PROCESS AT ALCON'S PUERTO RICO FACILITY FOR THE DUOVISC SYSTEM.