PMA P880031S011

Device: AMO(R) VITRAX(R) VISCOELASTIC SOLUTION
Applicant: Abbott Medical Optics, Inc.
PMA number: P880031
Supplement: S011
Product code: LZP
Decision date: 1997-04-09
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING SITE AT ALLERGAN BOTOX, LTD., WESTPORT, COUNTY MAYO, IRELAND; AN ALTERNATE CONTRACT STERILIZATION FACILITY, ISOTRON IRELAND, LTD., TULLAMORE, COUNTY OFFALY, IRELAND; AND AN 18 MONTH SHELF LIFE.

Current openFDA PMA Record#

Device: AMO(R) VITRAX(R) VISCOELASTIC SOLUTION
Applicant: Abbott Medical Optics, Inc.
PMA number: P880031
Supplement: S011
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 1997-04-09
Decision code: APPR
Date received: 1995-12-26
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING SITE AT ALLERGAN BOTOX, LTD., WESTPORT, COUNTY MAYO, IRELAND; AN ALTERNATE CONTRACT STERILIZATION FACILITY, ISOTRON IRELAND, LTD., TULLAMORE, COUNTY OFFALY, IRELAND; AND AN 18 MONTH SHELF LIFE.