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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 NameCSI(CROFILCON A)EXTENDED WEAR SOFT
Classification Namelenses, soft contact, extended wear
Generic Name(hydrophilic) contact lens
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberN17987
Supplement NumberS028
Date Received10/27/1999
Decision Date09/18/2000
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 manufacturing facility located at wesley jessen, inc. , cidra, puerto rico.
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