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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 NameNEWVUES, NEWVUES SOFTCOLORS, FOCUS, FOCUS VISITINT, AND FOCUS SOFTCOLORS (VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namesoft contact lenses
Regulation Number886.5925
ApplicantCIBA VISION CARE
PMA NumberP820021
Supplement NumberS025
Date Received01/17/1995
Decision Date12/13/1995
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 the lens blanks for newvues, newvues softcolors, focus, focus visitint, and focus softcolors (vifilcon a) soft (hydrophilic) contact lenses manufactured at ciba vision cororation, 2910 amwiler court, atlanta, ba to be final cured, wet processed, tinted, packged, and sterilizaed at the alternate manufacturing site, ciba vision batam, batam industrial park, lot #204, muka kuning 29433, batam island, indonesia.
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