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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.
 
DeviceDURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
CIBA VISION CORPORATION
11460 johns creek parkway
duluth, GA 30097
PMA NumberP850072
Supplement NumberS002
Date Received11/12/1987
Decision Date02/24/1988
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 88M-0082
Notice Date 03/30/1988
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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