| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | PRECISION(TM) UV (VASURFILCON) |
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| Generic Name | Lenses, soft contact, extended wear |
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| Applicant | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099 |
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| PMA Number | P940013 |
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| Supplement Number | S006 |
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| Date Received | 08/26/1998 |
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| Decision Date | 01/07/1999 |
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Withdrawal Date
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12/15/2014 |
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| Product Codes |
LPL LPM MVN |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for modifications to the labeling, including an additional indications statement, "Precision UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye"; and modified Note and Warning as stated below: "Warning: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses because they do not completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed." |
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