CSI (CROFILCON A) EXTENDED WEAR SOFT
FDA premarket approval N17987/S027 · decided 1999-11-18
Approval details
- PMA number
- N17987
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- CSI (CROFILCON A) EXTENDED WEAR SOFT
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Ciba Vision Corporation
- Date received
- 1999-09-01
- Decision date
- 1999-11-18
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Duluth, GA
- Statement
- Approval for a manufacturing site transfer of the CTL process for the CSI(TM) Lens from San Diego, CA to Wesley Jessen, Inc., Route 173, Kilometer 1.1, El Jibaro Industrial Park, P.O. Box 1980, Cidra, Puerto Rico 00739.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL (K133176) | Ciba Vision Corporation | 2014-01-29 |
| DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL (K123994) | Ciba Vision Corporation | 2013-02-21 |
| DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC (K113168) | Ciba Vision Corporation | 2012-03-30 |
| CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (K083216) | Ciba Vision Corporation | 2009-04-14 |
| CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES (K073459) | Ciba Vision Corporation | 2008-02-28 |
| CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (K072777) | Ciba Vision Corporation | 2008-01-24 |
| CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS (K062262) | Ciba Vision Corporation | 2006-11-14 |
| SOLO-CARE AQUA ANTIMICROBIAL LENS CASE (K041820) | Ciba Vision Corporation | 2005-09-09 |