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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 NumberS031
Date Received07/03/1997
Decision Date07/11/1997
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes in the Package Insert and Fitting and Patient Management Guide pertaining to the ACUVUE(R) BIFOCAL (etafilcon A) Contact Lens. The changes are designed to enhance practitioners' fitting performance and early visual success of the patient. No changes are made tot he remaining portions of approved labeling.
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