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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 BRAND (ETAFILCON A) DAILY EXTENDED WEAR CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantVISTAKON
PMA NumberN18033
Supplement NumberS034
Date Received11/03/2000
Decision Date05/18/2001
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding the manufacturing facility at vistakon, johnson & johnson (ireland) lte. , limerick, ireland, for the manufacture of accuvue(r) (etafilcon a) extended wear contact lenses.
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