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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.
 
DeviceH55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantThe Cooper Companies
6150 Stoneridge Mall Rd.
Suite 370
Pleasanton, CA 94588
PMA NumberP890023
Supplement NumberS003
Date Received09/29/1995
Decision Date07/12/1996
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR TINTING, WET PROCESSING, PACKAGING, AND STERILIZATION OF THE ABOVE-REFERENCED LENSES AT THE COMPANY'S FACILITY LOCATED AT SANTA ISABEL INDUSTRIAL PARK (FORMALLY KNOWN AS FELICIA WARD INDUSTRIAL PARK); HIGHWAY 538, KM 0.7, PUERTO RICO 00757
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