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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
11460 JOHNS CREEK PARKWAY
DULUTH, GA 30097
PMA NumberP850072
Supplement NumberS001
Date Received08/05/1986
Decision Date04/09/1987
Withdrawal Date 05/12/2009
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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