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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 NameNIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR UP TO 30 NIGHTS CONTINUOUS WEAR
Classification Namelenses, soft contact, extended wear
Generic Nameextended wear soft contact lenses
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP010019
Supplement NumberS006
Date Received04/02/2007
Decision Date07/26/2007
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised labeling for night & day (lotrafilcon a) soft contact lenses for up to 30 nights continuous wear.
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