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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.
 
DeviceBIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantTHE COOPER COMPANIES
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588
PMA NumberP890023
Supplement NumberS007
Date Received04/20/1999
Decision Date05/10/1999
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of a ultraviolet blocker into the matrix of the Biomedics 55 (ocufilcon D) soft (hydrophilic) lens for extended wear, a change in the indications statement to add the sentence "Biomedics UV Blocking Contact Lenses help protect against transmission of harmful UV radiation ot the cornea and in the eye;" and a modified Warning and Note.
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