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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 NameACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
PMA NumberN18033
Supplement NumberS029
Date Received07/18/1996
Decision Date10/07/1996
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 
Addition of a uv blocker, norbloc(r) 7966, to the approved molded etafilcon a extended wear contact lens (clear and with visibility tint), and a multi-focal design which was reviously cleared for the daily wear etafilcon a lens under k953804.
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