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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(R) THERAPEUTIC(TM) (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 NumberS024
Date Received02/02/1994
Decision Date02/13/1995
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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