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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 NameGENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namegentle touch uv
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP890012
Supplement NumberS004
Date Received03/25/1999
Decision Date09/12/2000
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) a change in manufacturing method from lathe-cut to cast-molded; 2) a change in handling tint from vat dyes to d & c green #6; 3) to add an ultraviolet absorber into netrafilcon a lens material; 4) an alternate manufacturing site at wesley jessen pbh, ltd. , southampton, united kingdom; 5) modification to the indicatinos for use including the sentence "gentle touch(tm) uv (netrafilcon a) soft (hydrophilic) contact lenses help to protect against the transmission of harmful uv radiation to the cornea and into the eye"; and 6) modification of the note and warning in labeling.
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