BAUSCH AND LOMB ALPHAFILCON A HYDROPHILIC CONTACT LENSES
FDA premarket approval P960022/S002 · decided 2002-06-28
Approval details
- PMA number
- P960022
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAUSCH AND LOMB ALPHAFILCON A HYDROPHILIC CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2001-01-09
- Decision date
- 2002-06-28
- Days to decision
- 535 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- 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.
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| BAUSCH & LOMB IOL INJECTOR (K113852) | Bausch & Lomb, Inc. | 2012-09-28 |
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