PMA P820049S061

Device: MODELS PC-58NBM & PC-58NBZ IOLS
Applicant: Advanced Medical Optics, Inc.
PMA number: P820049
Supplement: S061
Product code: HQL
Decision date: 1995-07-28
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR SINGLE-POUCH TYVEK PACKAGING OF LENSES PRODUCED IN IRVINE, CA & ANASCO, PR STERILIZATION OF LENSES USING PREVIOUSLY APPROVED 100% (ETO) STERILIZATION CYCLES & A 5 YEAR SHELF LIFE FOR SINGLE-POUCH/100% ETO STERILIZED LENSES

Current openFDA PMA Record#

Device: MODELS PC-58NBM & PC-58NBZ IOLS
Applicant: Advanced Medical Optics, Inc.
PMA number: P820049
Supplement: S061
Product code: HQL
Generic name: intraocular lens
Decision date: 1995-07-28
Decision code: APPR
Date received: 1995-04-04
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR SINGLE-POUCH TYVEK PACKAGING OF LENSES PRODUCED IN IRVINE, CA & ANASCO, PR STERILIZATION OF LENSES USING PREVIOUSLY APPROVED 100% (ETO) STERILIZATION CYCLES & A 5 YEAR SHELF LIFE FOR SINGLE-POUCH/100% ETO STERILIZED LENSES