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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 (HYDROPHILIC) CONTACT LENS
Classification Namelenses, soft contact, daily wear
Generic Name(hydrophilic) contact lens
Regulation Number886.5925
ApplicantWESLEY JESSEN CORP.
PMA NumberN17987
Supplement NumberS026
Date Received07/28/1999
Decision Date08/30/1999
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to transfer manufacturing of the csi lens to the manufacturing site located at wesley jessen, inc. , route 173, el jibaro industrial park, cidra, puerto rico.
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