PMA N17676
- Device
- Bausch & Lomb (hefilcon C) Contact Lenses
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- N17676
- Supplement
- S024
- Decision date
- 1993-07-02
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.