| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | PRECISION(TM) UV (VASURFILCON) |
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| Generic Name | Lenses, soft contact, extended wear |
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| Regulation Number | 886.5925 |
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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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| Date Received | 05/06/1994 |
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| Decision Date | 09/30/1994 |
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Withdrawal Date
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12/15/2014 |
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| Product Code |
LPM |
| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
FOR THE PRECISION (IV' (VASURFILCON A) HYDROPHILIC CONTACTLENS FOR EXTENDED WEAR. THIS DEVICE IS INDICATED FOR NON-APHAKIC DAILY OREXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING, RINSING, ANDDISINFECTING, AS RECOMMENDED BY THE EYE CARE PRACTITIONER. CANDIDATES TO USETHE PRECISION UV'" HYDROPHILIC CONTACT LENS INCLUDE PERSONS WHO ARE NEARSIGHTED(MYOPIC) AND FARSIGHTED (HYPEROPIC) AND WHO MAY HAVE ASTIGMATISM OF 2.0DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. |
| Supplements: |
S001 S002 S004 S005 S006 S007 S010 |
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