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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 NameSOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCIBA VISION CARE
PMA NumberP820021
Supplement NumberS009
Date Received02/02/1987
Decision Date04/17/1987
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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