DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES
FDA premarket approval P830037/S040 · decided 1997-05-15
Approval details
- PMA number
- P830037
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1996-12-18
- Decision date
- 1997-05-15
- Days to decision
- 148 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL TO ADD AN ULTRA VIOLET ABSORBER TO THE CLEAR AND LITETINE LATHE CUT POLYMER RODS FOR THE SUBJECT DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES DURASOFT(R)3 AND DURASOFT(R)3 UV (PHEMFILCON A) SPHERICAL AND OPTIFIT(R) TORIC CLEAR, LITETINT, COLORS, AND COLOR COMPLEMENTS SOFT (HYDROPHILIC) CONTACT LENSES (LATHE CUT) FOR EXTENDED WEAR WITH NO CHANGE IN THE CURRENTLY APPROVED INDICATIONS FOR USE.
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