| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES |
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| Classification Name | lenses, soft contact, extended wear |
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| Generic Name | balafilcon a visibility tinted contact lens |
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| Regulation Number | 886.5925 |
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| Applicant | BAUSCH & LOMB, INC. |
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| PMA Number | P980006 |
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| Supplement Number | S004 |
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| Date Received | 05/30/2001 |
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| Decision Date | 11/20/2001 |
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| Product Code | |
| Docket Number | 01M-0531 |
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| Notice Date | 11/29/2001 |
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| Advisory Committee |
Ophthalmic |
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| Supplement Type | panel track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the pure vision (balafilcon a) visibility tinted contact lens. The device is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2. 00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for frequent/planned replacement wear or disposable wear in spherical powers ranging from +8. 00d to -20. 00d when prescribed for up to 30 days of extended wear and from +20. 00d to -20. 00d for daily wear or extended wear up to 7 days. |
| Approval Order |
Approval Order
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