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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
Generic NameLenses, soft contact, extended wear
ApplicantVISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
7500 CENTURION PKWY.
JACKSONVILLE, FL 32256
PMA NumberN18033
Supplement NumberS029
Date Received07/18/1996
Decision Date10/07/1996
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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