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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
Trade NamePRECISION(TM) UV (VASURFILCON)
Classification Namelenses, soft contact, extended wear
Generic Namecontact lens
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP940013
Supplement NumberS006
Date Received08/26/1998
Decision Date01/07/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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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