PMA P980006S003

Device: BAUSCH AND LOMB BALAFILCON A HYDROPHILIC CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: P980006
Supplement: S003
Product code: LPM
Decision date: 2002-06-28
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: APPROVAL FOR AN ALTERNATE BIOLOGICAL INDICATOR, THE 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR, TO MONITOR THE STERILIZATION PROCESSES AND TO USE ONLY THE FLUORESCENT ENZYME 3 HOUR READOUT SYSTEM FOR ROUTINE DISPOSITION OF THE PRODUCT. THE FLUORESCENT READOUT SYSTEM BY ITSELF WILL NOT BE USED TO VALIDATE THE STERILIZATION PROCESSES.

Current openFDA PMA Record#

Device: BAUSCH AND LOMB BALAFILCON A HYDROPHILIC CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: P980006
Supplement: S003
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2002-06-28
Decision code: APPR
Date received: 2001-01-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN ALTERNATE BIOLOGICAL INDICATOR, THE 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR, TO MONITOR THE STERILIZATION PROCESSES AND TO USE ONLY THE FLUORESCENT ENZYME 3 HOUR READOUT SYSTEM FOR ROUTINE DISPOSITION OF THE PRODUCT. THE FLUORESCENT READOUT SYSTEM BY ITSELF WILL NOT BE USED TO VALIDATE THE STERILIZATION PROCESSES.