GENTLETOUCH (NETRAFILCON A)EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS
FDA premarket approval P890012/S005 · decided 2000-05-02
Approval details
- PMA number
- P890012
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- GENTLETOUCH (NETRAFILCON A)EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Ciba Vision Corporation
- Date received
- 2000-02-28
- Decision date
- 2000-05-02
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Duluth, GA
- Statement
- Approval for a manufacturing site transfer to Wesley Jessen Inc., Cidra, Puerto Rico.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |