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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 NumberS030
Date Received05/02/1997
Decision Date05/14/1997
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to make a minor change in the initiator ratio (increased amount) for the acuvue(r) (etafilcon a) contact lens, which was approved as n18-033/s29 on october 7, 1996. The device, as modified, will be marketed under the current trade name with no change to the indications for use or the established shelf-life.
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