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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceOCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
THE COOPER COMPANIES
6150 stoneridge mall road
suite 370
pleasanton, CA 94588
PMA NumberP890023
Supplement NumberS004
Date Received10/02/1995
Decision Date08/28/1996
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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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