NDS LENS MAINTENANCE SYSTEM
FDA premarket approval P900029/S001 · decided 1995-08-01
Approval details
- PMA number
- P900029
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NDS LENS MAINTENANCE SYSTEM
- Generic name
- Accessories, soft lens products
- Applicant
- Ciba Vision Corporation
- Date received
- 1995-06-02
- Decision date
- 1995-08-01
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- APPROVAL FOR LABELING CHANGES TO ENHANCE THE INSTRUCTIONS TO BETTER COMMUNICATE THE PROPER LENS STORAGE TIMEFRAMES WHEN USING THE QUICK CARE SYSTEM.
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| 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 |