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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 NumberS031
Date Received07/03/1997
Decision Date07/11/1997
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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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