PMA N17676S028

Device: BAUSCH AND LOMB HEFILCON A, B AND C HYDROPHILIC CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: N17676
Supplement: S028
Product code: LPL
Decision date: 2002-06-28
Classification: Ophthalmic
Generic name: Lenses, soft contact, daily 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 HEFILCON A, B AND C HYDROPHILIC CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: N17676
Supplement: S028
Product code: LPL
Generic name: Lenses, soft contact, daily 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.