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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.
 
DeviceOCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR 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 NumberS004
Date Received10/02/1995
Decision Date08/28/1996
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING: 1)MODIFYING THE MANUFACTURING PROCESS FOR THE OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR LENSES FROM A LOCATOR TINT DIPPING PROCESS AT THE END OF THE MANUFACTURING PROCEDURE TO THE ADDITION OF AN IN-MONOMER TINT INCORPORATING VAT BLUE 6 DYE DURING THE POLYMERIZATION PHASE OF THE MANUFACTURING PROCESS; 2)USING BLISTER PACKAGINAS ALTERNATE PACKAGING MATERIAL; AND 3)ADDING THE FOLLOWING ALTERNATE MANUFACTUIRING SITE FOR LENSES MANUFACTURED BY THE PROCESS DESCRIBED IN ITEM 1: OCULAR SCIENCES/AMERICAN HYDRON, CHANDLERS FORD INDUSTRIAL ESTATE, CHANDLERS FORD, EASTLEIGH, HAMPSHIRE S053 4 ND, ENGLAND
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