VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
FDA premarket approval P040045 · decided 2005-12-20
Approval details
- PMA number
- P040045
- Trade name
- VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Division of Johnson & Johnson Vision Car
- Date received
- 2004-11-15
- Decision date
- 2005-12-20
- Days to decision
- 400 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR THE VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER. THE DEVICE IS INDICATED FOR USE AS FOLLOWS: THE VISTAKON (SENOFILCON A) SOFT CONTACT LENS (SPHERICAL) IS INDICATED FOR THE OPTICAL CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN PHAKIC OR APHAKIC PERSONS WITH NON-DISEASED EYES WHO HAVE 1.00D OR LESS OF ASTIGMATISM. THE VISTAKON (SENOFILCON A) MULTIFOCAL SOFT CONTACT LENS IS INDICATED FOR THE OPTICAL CORRECTION OF DISTANCE AND NEAR VI
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