PMA P820049S063

Device: MODELS PC-58NBM & PC-58NBZ IOLS
Applicant: Advanced Medical Optics, Inc.
PMA number: P820049
Supplement: S063
Product code: HQL
Decision date: 1996-03-11
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL TO ADD STERILIZATION SERVICES OF TENNESSEE (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE FOR IOLS PRODUCED IN IRVINE, CA AND ANASCO, PR AND PACKAGED IN THE SINGLE-POUCH TYVEK PACKAGING CONFIGURATION CURRENTLY APPROVED UNDER THESE PMAS FOR STERILIZATION AT STERILIZATION SERVICES OF GEORGIA (SSG)

Current openFDA PMA Record#

Device: MODELS PC-58NBM & PC-58NBZ IOLS
Applicant: Advanced Medical Optics, Inc.
PMA number: P820049
Supplement: S063
Product code: HQL
Generic name: intraocular lens
Decision date: 1996-03-11
Decision code: APPR
Date received: 1995-11-13
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO ADD STERILIZATION SERVICES OF TENNESSEE (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE FOR IOLS PRODUCED IN IRVINE, CA AND ANASCO, PR AND PACKAGED IN THE SINGLE-POUCH TYVEK PACKAGING CONFIGURATION CURRENTLY APPROVED UNDER THESE PMAS FOR STERILIZATION AT STERILIZATION SERVICES OF GEORGIA (SSG)