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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 NameFOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Nameextended wear soft contact lenses
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP010019
Supplement NumberS001
Date Received04/05/2002
Decision Date07/05/2002
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the revised post-approval study protocol for the device. The post-approval study protocol was submitted to comply with the conditions of approval outlined in the october 11, 2001 approval order for p010019.
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