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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
ApplicantWESLEY JESSEN CORP.
PMA NumberN17987
Supplement NumberS027
Date Received09/01/1999
Decision Date11/18/1999
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 a manufacturing site transfer of the ctl process for the csi(tm) lens from san diego, ca to wesley jessen, inc. , route 173, kilometer 1. 1, el jibaro industrial park, p. O. Box 1980, cidra, puerto rico 00739.
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