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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 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
Classification Namelenses, soft contact, extended wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantVISTAKON
PMA NumberN18033
Supplement NumberS038
Date Received12/16/2002
Decision Date01/08/2003
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternative binding polymer to the acuvue 2 colours brand (etafilcon a) soft (hydrophilic) contact lens with uv blocker.
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