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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 Pkwy.
Duluth, GA 30097
PMA NumberP850072
Supplement NumberS002
Date Received11/12/1987
Decision Date02/24/1988
Withdrawal Date05/12/2009
Product Code 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 ProductNo
Predetermined Change Control Plan AuthorizedNo
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