PMA P840064S015

Device: VISCOAT VISCOELASTIC SYSTEM
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S015
Product code: LZP
Decision date: 1996-03-22
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR: 1)ALTERNATE MANUFACTURING SITE AT PUURS, BELGIUM; 2)USE OF 100% ETHYLENE OXIDE IN THE STERILIZATION PROCESS; AND 3)INCREASE IN THE ALLOWABLE FILL VOLUME TO 0.75 ML (THIS WAS INADVERTENTLY NOT INCLUDED IN OUR APPROVABLE LETTER OF 13-FEB-96)

Current openFDA PMA Record#

Device: VISCOAT VISCOELASTIC SYSTEM
Applicant: Alcon Laboratories
PMA number: P840064
Supplement: S015
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 1996-03-22
Decision code: APPR
Date received: 1995-08-14
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR: 1)ALTERNATE MANUFACTURING SITE AT PUURS, BELGIUM; 2)USE OF 100% ETHYLENE OXIDE IN THE STERILIZATION PROCESS; AND 3)INCREASE IN THE ALLOWABLE FILL VOLUME TO 0.75 ML (THIS WAS INADVERTENTLY NOT INCLUDED IN OUR APPROVABLE LETTER OF 13-FEB-96)